For use in adults infusion solution for intravenous use

Application / Use

Electrolyte infusion solution 153 with glucose 5 is an infusion solution administered into a vein.

This solution replaces fluid, salts and sugars lost from the circulatory system. It can also be used in cases where your blood is slightly acidic.

The solution can also be used as a carrier solution for other salts and medicines.

Active ingredients / components

1 l infusion solution contains the following active ingredients:

(A mmol/l: Na+ 140, K+ 5, Ca2+ 2.5, Mg2+ 1.5, Cl- 103, acetate ions 50)

The other ingredients are water for injection and hydrochloric acid 36 %.

Sterile and pyrogen-free. pH: 5.0 - 6.0

Energy content: 840 kJ/l (200 kcal/l)

Theoretical osmolarity: 581 mOsm/l Titration acidity: < 3 mmol/l to pH 7.4

Electrolyte infusion solution 153 with glucose 5 is available in glass bottles in the following package sizes:

1 x 500 ml

10 x 500 ml

E 148 G1 PÄD prevents derailments:

• of plasma electrolytes, especially hyper- and hyponatremia
• of the plasma glucose concentration
• of the acid-base balance

Active ingredient

Sodium chloride 6.429 g, potassium chloride 0.298 g, calcium chloride dihydrate 0.147 g, magnesium chloride hexahydrate 0.203 g, sodium acetate trihydrate 4.082 g, glucose monohydrate 11.0 g

For further information, please refer to the technical information.

Substitution of fluids and electrolytes with low percentage carbohydrate, especially in postoperative and post-traumatic infusion therapy, when the application of sodium-rich drugs is additional

Carrier solution for compatible electrolyte concentrates and drugs

Active ingredients / components

• 1 l infusion solution contains:
• Potassium chloride 1.86 g
• Magnesium chloride hexahydrate 0.51 g
• Sodium acetate trihydrate 2.72 g
• Sodium chloride 0.88 g
• Sodium dihydrogen phosphate dihydrate 1.56 g
• Glucose monohydrate 55.00 g
• (^ mmol/l: Na+ 45, K+ 25, Mg2+ 2.5, Cl- 45, acetate ions 20, H2PO4- 10).

Other ingredients:

• Water for injection, hydrochloric acid 36 %.
• Sterile and pyrogen-free.
• pH: 5.0 - 6.0
• Energy content: 840 kJ/l (200 kcal/l)
• Theoretical osmolarity: 436 mOsm/l
• Titration acidity: ? 12 mmol/l to pH 7.4
• Infusion solution in glass bottles.

For bowel cleansing before any diagnostic examination that can be meaningfully performed only if the bowel is well cleansed, e.g. a colonoscopy or X-ray examination. CitraFleet is used in adults 18 years and older.

Product information

• CitraFleet is the first NP&MC product in Europe that allows split application
• Clean bowel for effective mucosal detection
• For thorough emptying and cleaning
• Lower dosage required

Features

• Pleasant lemon taste
• Easier to take than PEG 2L + Asc6
• Better tolerated & better accepted by patients than PEG 2L + Asc and 4L6 7
• Less nausea & vomiting than PEG 4L7
• High efficacy
• High washout effect

For bowel cleansing before any diagnostic examination that can be meaningfully performed only if the bowel is well cleansed, e.g. a colonoscopy or X-ray examination. CitraFleet is used in adults 18 years and older.

Product information

• CitraFleet is the first NP&MC product in Europe that allows split application
• Clean bowel for effective mucosal detection
• For thorough emptying and cleaning
• Lower dosage required

Features

• Pleasant lemon taste
• Easier to take than PEG 2L + Asc6
• Better tolerated & better accepted by patients than PEG 2L + Asc and 4L6 7
• Less nausea & vomiting than PEG 4L7
• High efficacy
• High washout effect

Without anticoagulant for the preparation of lightly concentrated platelet-rich plasma.

Application

wPRP - Acute:

• Tendon injuries, including Achilles tendon, rotator cuff
• Ligament injuries, e.g. cruciate ligament, ankle ligaments
• Muscle fiber tear
• Meniscus injury

wPRP – Chronic

• Tendinopathy, e.g., Achilles tendon thickening/ Chronic Achilles tendon rupture (Achillodynia)
• Tendon irritation, e.g. patellar tendon syndrome
• Subacromial syndrome
• Tendonitis

Concentration / Yield

Restoric nephro intra D supports nutrition to meet requirements in the context of dietary management in the event of existing or impending malnutrition and food intake disorders.

The drinkable food is specially adapted to the needs of patients with renal insufficiency requiring dialysis.

How much restoric nephro intra D should be taken - and when?

The amount to be taken depends on the degree of malnutrition and is prescribed by the physician.

In case of exclusive nutrition with restoric nephro intra D, the dosage must be further increased and adapted to the individual energy requirements of the patient.

Restoric nephro intraD can be taken at any time. In case of supplementary nutrition, the sip feed should be taken as a snack.

Properties

• Effortless replenishment of energy and protein stores
• Small drinking volume
• Quick and easy to prepare
• More freedom in food selection due to
• less import of potassium and phosphate
• Long-term taste acceptance confirmed in study
• Give your patients back their strength!
• Contains: 24x cookie

Restoric nephro intra D supports nutrition to meet requirements in the context of dietary management in the event of existing or impending malnutrition and food intake disorders.

The drinkable food is specially adapted to the needs of patients with renal insufficiency requiring dialysis.

How much restoric nephro intra D should be taken - and when?

The amount to be taken depends on the degree of malnutrition and is prescribed by the physician.

In case of exclusive nutrition with restoric nephro intra D, the dosage must be further increased and adapted to the individual energy requirements of the patient.

Restoric nephro intraD can be taken at any time. In case of supplementary nutrition, the sip feed should be taken as a snack.

Properties

• Effortless replenishment of energy and protein stores
• Small drinking volume
• Quick and easy to prepare
• More freedom in food selection due to
• less import of potassium and phosphate
• Long-term taste acceptance confirmed in study
• Give your patients back their strength!
• Contains: 24x cookie

Restoric nephro intra D supports nutrition to meet requirements in the context of dietary management in the event of existing or impending malnutrition and food intake disorders.

The drinkable food is specially adapted to the needs of patients with renal insufficiency requiring dialysis.

How much restoric nephro intra D should be taken - and when?

The amount to be taken depends on the degree of malnutrition and is prescribed by the physician.

In case of exclusive nutrition with restoric nephro intra D, the dosage must be further increased and adapted to the individual energy requirements of the patient.

Restoric nephro intraD can be taken at any time. In case of supplementary nutrition, the sip feed should be taken as a snack.

Properties

• Effortless replenishment of energy and protein stores
• Small drinking volume
• Quick and easy to prepare
• More freedom in food selection due to
• less import of potassium and phosphate
• Long-term taste acceptance confirmed in study
• Give your patients back their strength!
• Contains: 24x cookie

Restoric nephro intra D supports nutrition to meet requirements in the context of dietary management in the event of existing or impending malnutrition and food intake disorders.

The drinkable food is specially adapted to the needs of patients with renal insufficiency requiring dialysis.

How much restoric nephro intra D should be taken - and when?

The amount to be taken depends on the degree of malnutrition and is prescribed by the physician.

In case of exclusive nutrition with restoric nephro intra D, the dosage must be further increased and adapted to the individual energy requirements of the patient.

Restoric nephro intraD can be taken at any time. In case of supplementary nutrition, the sip feed should be taken as a snack.

Properties

• Effortless replenishment of energy and protein stores
• Small drinking volume
• Quick and easy to prepare
• More freedom in food selection due to
• less import of potassium and phosphate
• Long-term taste acceptance confirmed in study
• Give your patients back their strength!
• Contains: 24x cookie

Restoric nephro intra D supports nutrition to meet requirements in the context of dietary management in the event of existing or impending malnutrition and food intake disorders.

The drinkable food is specially adapted to the needs of patients with renal insufficiency requiring dialysis.

How much restoric nephro intra D should be taken - and when?

The amount to be taken depends on the degree of malnutrition and is prescribed by the physician.

In case of exclusive nutrition with restoric nephro intra D, the dosage must be further increased and adapted to the individual energy requirements of the patient.

Restoric nephro intraD can be taken at any time. In case of supplementary nutrition, the sip feed should be taken as a snack.

Properties

• Effortless replenishment of energy and protein stores
• Small drinking volume
• Quick and easy to prepare
• More freedom in food selection due to
• less import of potassium and phosphate
• Long-term taste acceptance confirmed in study
• Give your patients back their strength!
• Contains: 24x cookie

The right tube feeding from the beginning facilitates intensive therapy and promotes long-term stability even in outpatient care.

Intensive care in nephrology, cardiology and surgery.

Due to its special composition, Restoric Nephro intensive contributes to metabolic stability, promotes convalescence and can thus lead to a shorter stay in the intensive care unit.

The sip and tube feed nutrition is specially adapted to the needs of patients with renal insufficiency requiring dialysis.

How much restoric nephro intensiv should be taken - and when?

The amount to be taken depends on the degree of malnutrition and is prescribed by the physician.

In case of supplementary nutrition:

For exclusive nutrition:

The energy requirement of dialysis patients is given as 30-35 kcal/kg target body weight.

The table shows guideline values, but energy requirements may be significantly lower or higher than these values in individual cases and must always be adjusted to individual needs.

Restoric nephro intensive can be taken as a drinkable food at any time. In the case of supplementary nutrition, the drinkable food should be taken as a snack.

PropyBAG - Saline bags for use in dialysis centers and hospitals

Advantages

• Use of plasticizer-free PP film for bag production
• Very good collapsibility even with pressure infusions
• Easy connection due to Luer-Lock screw cap technology
• Safe sterilization in accordance with the pharmacopoeia
• Tight quality control for leakage and particles
• User-friendly packaging 

The saline bags are available in four different sizes: 250 ml, 500 ml, 1000 ml and 2000 ml

Areas of application

Fluid and electrolyte substitution in hypochloremic alkalosis, chloride losses, short-term intravascular volume replacement, hypotonic dehydration, isotonic dehydration

PropyBAG - Saline bags for use in dialysis centers and hospitals

Advantages

• Use of plasticizer-free PP film for bag production
• Very good collapsibility even with pressure infusions
• Easy connection due to Luer-Lock screw cap technology
• Safe sterilization in accordance with the pharmacopoeia
• Tight quality control for leakage and particles
• User-friendly packaging 

The saline bags are available in four different sizes: 250 ml, 500 ml, 1000 ml and 2000 ml

Areas of application

Fluid and electrolyte substitution in hypochloremic alkalosis, chloride losses, short-term intravascular volume replacement, hypotonic dehydration, isotonic dehydration

PropyBAG - Saline bags for use in dialysis centers and hospitals

Advantages

• Use of plasticizer-free PP film for bag production
• Very good collapsibility even with pressure infusions
• Easy connection due to Luer-Lock screw cap technology
• Safe sterilization in accordance with the pharmacopoeia
• Tight quality control for leakage and particles
• User-friendly packaging 

The saline bags are available in four different sizes: 250 ml, 500 ml, 1000 ml and 2000 ml

Areas of application

Fluid and electrolyte substitution in hypochloremic alkalosis, chloride losses, short-term intravascular volume replacement, hypotonic dehydration, isotonic dehydration

PropyBAG - Saline bags for use in dialysis centers and hospitals

Advantages

• Use of plasticizer-free PP film for bag production
• Very good collapsibility even with pressure infusions
• Easy connection due to Luer-Lock screw cap technology
• Safe sterilization in accordance with the pharmacopoeia
• Tight quality control for leakage and particles
• User-friendly packaging 

The saline bags are available in four different sizes: 250 ml, 500 ml, 1000 ml and 2000 ml

Areas of application

Fluid and electrolyte substitution in hypochloremic alkalosis, chloride losses, short-term intravascular volume replacement, hypotonic dehydration, isotonic dehydration

What is Spherox?

SPHEROX is the only EMA-approved ATMP for the treatment of cartilage damage.

Spherox consists of so-called spheroids. A spheroid looks like a small bead of cartilage cells and cartilage material that come from your own body. The spheroids are implanted into the damaged cartilage area and immediately adhere to the damaged area.

Keyfacts

• Patient's own cartilage cells
• Spheroids with 100% autologous matrix
• Minimally invasive and self-adhesive
• Cartilage damage <= 10 cm²
• Femoral condyle and patella
• Demonstrates significant improvement
• Personalized process

Personalisierter Prozess

Biopsy

• A small sample of cartilage and blood is collected
• Indicated for cartilage defects in the knee up to 10 cm²
• In adults (18 to 50 years)

Cultivation

• A specialized biotechnologist takes care of the complete cultivation process
• Consistently good quality according to GMP

Transplantation

• Leads to personalized healing of the cartilage defect
• Is applied by means of minimally invasive surgery
• Utilizes Spheroid Technology™

Restoric nephro intra D supports nutrition to meet requirements in the context of dietary management in the event of existing or impending malnutrition and food intake disorders.

The drinkable food is specially adapted to the needs of patients with renal insufficiency requiring dialysis.

How much restoric nephro intra D should be taken - and when?

The amount to be taken depends on the degree of malnutrition and is prescribed by the physician.

In case of exclusive nutrition with restoric nephro intra D, the dosage must be further increased and adapted to the individual energy requirements of the patient.

Restoric nephro intraD can be taken at any time. In case of supplementary nutrition, the sip feed should be taken as a snack.

Properties

• Effortless replenishment of energy and protein stores
• Small drinking volume
• Quick and easy to prepare
• More freedom in food selection due to
• less import of potassium and phosphate
• Long-term taste acceptance confirmed in study
• Give your patients back their strength!
• Contains: 24x cookie

Restoric nephro intra D supports nutrition to meet requirements in the context of dietary management in the event of existing or impending malnutrition and food intake disorders.

The drinkable food is specially adapted to the needs of patients with renal insufficiency requiring dialysis.

How much restoric nephro intra D should be taken - and when?

The amount to be taken depends on the degree of malnutrition and is prescribed by the physician.

In case of exclusive nutrition with restoric nephro intra D, the dosage must be further increased and adapted to the individual energy requirements of the patient.

Restoric nephro intraD can be taken at any time. In case of supplementary nutrition, the sip feed should be taken as a snack.

Properties

• Effortless replenishment of energy and protein stores
• Small drinking volume
• Quick and easy to prepare
• More freedom in food selection due to
• less import of potassium and phosphate
• Long-term taste acceptance confirmed in study
• Give your patients back their strength!
• Contains: 24x cookie

Restoric nephro intra D supports nutrition to meet requirements in the context of dietary management in the event of existing or impending malnutrition and food intake disorders.

The drinkable food is specially adapted to the needs of patients with renal insufficiency requiring dialysis.

How much restoric nephro intra D should be taken - and when?

The amount to be taken depends on the degree of malnutrition and is prescribed by the physician.

In case of exclusive nutrition with restoric nephro intra D, the dosage must be further increased and adapted to the individual energy requirements of the patient.

Restoric nephro intraD can be taken at any time. In case of supplementary nutrition, the sip feed should be taken as a snack.

Properties

• Effortless replenishment of energy and protein stores
• Small drinking volume
• Quick and easy to prepare
• More freedom in food selection due to
• less import of potassium and phosphate
• Long-term taste acceptance confirmed in study
• Give your patients back their strength!
• Contains: 24x cookie

For cental venous infusion after addition to infusion solutions

Indications

• Decreased sodium content of the blood (hyponatremia)
• reduced chloride content of the blood (hypochloremia)
• hypotonic hyperhydration

Precautions for use

• Special precautions should be taken in case of
• decreased blood potassium (hypokalemia)
• increased blood sodium (hypernatremia)
• increased chloride content of the blood (hyperchloremia)
• Conditions requiring restrictive sodium intake (e.g., congestive heart failure, generalized edema, pulmonary edema, hypertension, eclampsia, severe renal failure).

See also under warnings.

Pregnancy or lactation

There are no objections to use during pregnancy or lactation.

Qualitative and quantitative composition

1 l infusion solution concentrate contains:

Active ingredient:

Sodium chloride 58.44 g

(≙mmol/ml: Na⁺1, CI- 1).

Other ingredient:

Water for injections.

Sterile and pyrogen-free.

Ph: 4.5-7.0

Theoretical osmolarity: 2 000 mOsm/l

Titration acidity up to pH 7.4: <0.3 mmoI/I

Please refer to the Instructions for Use for more details.

for intravenous infusion after addition to infection solutions

Indications

• potassium deficiency, especially in hypochloremic alkalosis

Precautions for use

• Particular caution should be exercised in
• renal dysfunction
• Hyperchloremia

Mode of administration

• For intravenous infusion after addition to infusion solutions

See also warnings

Pregnancy and lactation

There are no objections to use during pregnancy and lactation when indicated.

Qualitative and quantitative composition

1000 ml infusion solution concentrate contains:

Active ingredient:

Potassium chloride 74.56 g

(≙mmol/ml: K⁺ 1, CI- 1).

Other ingredient:

Water for injections.

Sterile and pyrogen-free.

pH: 4.5 - 7.5

Theoretical osmolarity: 2000 mOsm/l

For more details, please refer to the instructions for use.

for intravenous infusion after addition to infection solutions

Indications

• potassium deficiency, especially in hypochloremic alkalosis

Precautions for use

• Particular caution should be exercised in
• renal dysfunction
• Hyperchloremia

Mode of administration

• For intravenous infusion after addition to infusion solutions

See also warnings

Pregnancy and lactation

There are no objections to use during pregnancy and lactation when indicated.

Qualitative and quantitative composition

1000 ml infusion solution concentrate contains:

Active ingredient:

Potassium chloride 74.56 g

(≙mmol/ml: K⁺ 1, CI- 1).

Other ingredient:

Water for injections.

Sterile and pyrogen-free.

pH: 4.5 - 7.5

Theoretical osmolarity: 2000 mOsm/l

For more details, please refer to the instructions for use.

Food for special medical purposes (balanced diet) for dietary management in cases of existing or threatened malnutrition as well as in cases of food intake disorders: high-protein, high-calorie, completely balanced drinkable food with dietary fiber.

Properties

restoric supportiv S Vegan supports dietary management in cases of existing or impending malnutrition as well as in cases of food intake disorders.

The drinkable food is specially adapted to the needs of patients with malnutrition due to illness or age:

• high in protein (20 E% protein)
• high caloric (1,5 kcal/ml)
• fully balanced (contains all vitamins, trace elements, minerals)
• vegan
• gluten-free
• naturally lactose-free
• prescribable

How much restoric supportiv S Vegan should be taken - and when?

The amount to be taken depends on the degree of malnutrition and is prescribed by the doctor.

For exclusive nutrition, the dosage is to be calculated according to the individual energy requirement.

restoric supportiv S Vegan should be taken as a snack.

The intake of restoric supportiv S Vegan can take place at any time. In case of supplementary nutrition, the drinkable food should be taken as a snack. In this case, restoric supportiv S Vegan can be taken as a second breakfast, in the afternoon or before going to bed. It is recommended to drink the supplementary food one hour after a main meal rather than one hour before a larger meal.

Active substance: nalbuphine hydrochloride

What is Nubain and what is it used for?

Nubain contains the active ingredient nalbuphine hydrochloride, which is a medicine that belongs to the group of opioid-type painkillers (analgesics).

It is used for short-term treatment of moderate to severe pain.

It may also be used to treat pain before or after surgery.

Route of administration

Intravenous, intramuscular, or subcutaneous use.

Because intramuscular and subcutaneous use can be painful, intravenous use is preferred in children.

What Nubain contains

• The active ingredient is: Nalbuphine hydrochloride.
  1 ml of solution for injection contains 10 mg of nalbuphine hydrochloride.

1 ampoule of 2 ml contains 20 mg of nalbuphine hydrochloride.

• The other ingredients are:
  Citric acid monohydrate, sodium citrate dihydrate, sodium chloride, water for injection.

Pharmaceutical entrepreneur and manufacturer

Pharmaceutical entrepreneur

Altamedics GmbH

Josef-Lammerting-Allee 16

50933 Cologne

Germany

Manufacturer

Laboratoire Renaudin

Z.A. Errobi

64250 Itxassou

France

For further information please refer to the instructions for use

Composition

Medically active ingredient 1 ampoule containing 52.75 mg lyophilizate for the preparation of an infusion solution contains nitroprusside sodium, anhydrous (corresponding to 60 mg nitroprusside sodium 2 H2O).

Other ingredients: None.

Indications

Hypertensive crises, controlled hypotension during surgery.

Contraindications:

Nipruss must not be used if you are allergic to nitroprusside sodium; in cases of congenital pathological narrowing of the aorta in the transition area of the aortic arch to the main aortic branch (aortic isthmic stenosis); in cases of hereditary atrophy of fibers of the optic nerve (Leber's optic atrophy); in cases of bilateral, usually irreversible visual loss in color perception due to chronic tobacco abuse (tobacco amblyopia); in cases of vitamin B12 deficiency; in cases of metabolic acidosis of the blood and body (metabolic acidosis); in cases of hypothyroidism; in cases of existing short-circuit connection between arterial and venous blood vessels within the lungs (intra-pulmonary arteriovenous shunts).

Side effects

Feeling of weakness, dizziness, nausea, vomiting, tachycardia.

Indications of cyanide poisoning: bright red venous blood, hypoventilation, lactate increase, decreased oxygen uptake, palpitations, headache, metabolic acidosis, coma, cardiac arrhythmias, respiratory paralysis, and convulsions. Deaths have been described. Cyanide poisoning is completely preventable with concurrent infusion of sodium thiosulfate.

Inadequate blood pressure reduction and occurrence of tachyphylaxis or tolerance are more likely in younger than in older hypertensives.

Warnings

Keep drug out of reach of children.

Prescription Only.

Pharmaceutical entrepreneur

ALTAMEDICS GmbH, Josef-Lammerting-Allee 16, D-50933 Cologne, Germany.

For further information and warnings and precautions, please refer to the SmPC.

Food for special medical purposes (balanced diet) for dietary management in cases of existing or threatened malnutrition as well as in cases of food intake disorders: high-protein, high-calorie, completely balanced drinkable food with dietary fiber.

Properties

restoric supportiv S Vegan supports dietary management in cases of existing or impending malnutrition as well as in cases of food intake disorders.

The drinkable food is specially adapted to the needs of patients with malnutrition due to illness or age:

• high in protein (20 E% protein)
• high caloric (1,5 kcal/ml)
• fully balanced (contains all vitamins, trace elements, minerals)
• vegan
• gluten-free
• naturally lactose-free
• prescribable

How much restoric supportiv S Vegan should be taken - and when?

The amount to be taken depends on the degree of malnutrition and is prescribed by the doctor.

For exclusive nutrition, the dosage is to be calculated according to the individual energy requirement.

restoric supportiv S Vegan should be taken as a snack.

The intake of restoric supportiv S Vegan can take place at any time. In case of supplementary nutrition, the drinkable food should be taken as a snack. In this case, restoric supportiv S Vegan can be taken as a second breakfast, in the afternoon or before going to bed. It is recommended to drink the supplementary food one hour after a main meal rather than one hour before a larger meal.

Available in sizes 2x2cm and 5x5cm.

In combination with mesenchymal stem cells (MSCs), it supports the regeneration of hyaline cartilage.

Effective

Excellent clinical and mid-term MRI results in the treatment of osteochondral defects of the ankle and knee. Hyaline-like cartilage confirmed by MRI T2 mapping

Versatile

Functions as a scaffold for bone marrow aspirate or as a chondroprotective cover after microfracture or perforation procedure

Safe

Not of animal origin. Excellent safety profile based on over 15 years of experience with HYAFF® products in clinical applications

Excellent handling properties

• Hyalofast® can be easily applied during arthroscopy or mini-arthrotomy procedures
• Due to its soft texture, Hyalofast® easily adapts to any lesion shape
• Due to its self-adhesive properties, it can be used in most cases without additional fixation.
• Thanks to its uniform three-dimensional structure, the cell carrier can be applied in any orientation or overlaid.
• Two available sizes also allow easy coverage of large lesions
• Unique composition
• A safe step towards regeneratio
• Three-dimensional nonwoven matrix
• After implantation, HyaloFast retains its 3D nonwoven structure for a period that supports adhesion and 3D organization of mesenchymal stem cells (MSCs), facilitating restoration of the original tissue anatomy.
• Embryonic environment
• As HYAFF fibers degrade, hyaluronic acid (HS) is released in the lesion, creating a HS-rich microenvironment.

Safe and bio-absorbable

HyaloFast has been used in tissue regeneration for more than 15 years and has an excellent safety profile. When HYAFF is degraded to HS, it is naturally absorbed into the body. HyaloFast is not an animal product.

Cell carrier that can be used in a variety of ways for cartilage regeneration.

HyaloFast with microfacturing

HyaloFast overcomes the challenge by acting as a chondroprotective cover that ensures MSC remain in situ after mobilization and promotes the formation of a stable and adhesive blood clot that fills the cartilage damage.

HyaloFast with bone marrow aspirate concentrate (BMAC)

HyaloFast supports bone marrow aspirate, which can be applied to HyaloFast.

Thanks to its hydrophilic properties, HyaloFast allows rapid and homogeneous distribution of BMAC fluid.

HyaloFast Indications

HyaloFast carries the CE mark for the harvesting of mesenchymal stem cells for the treatment of chondral and osteochondral lesions.

Hyalofast® is indicated for the treatment of chondral or osteochondral defects:

• ICRS Grades III and IV
• Single or multiple

Caused by:

• acute trauma
• repeated microtrauma
• Instability and / or malalignment (associated with reconstructive and / or corrective surgery)
• Osteochondritis Dissecans (OCD)

MARROW CELLUTION™ is an innovative instrument for the aspiration of bone marrow and cancellous bone.

MARROW CELLUTION™ enables aspiration of bone marrow with high cellular content

One puncture - multiple aspiration sites in the marrow space

INNOVATION

Reduces peripheral blood contamination - Closed system - Controlled movement of the cannula in the space

EFFICIENCY

Minimally invasive - One puncture - Many aspirates - Low aspirate volume - High cell yield - No centrifugation required

PERFORMANCE 

Higher CFU-f count per ml - Simultaneous recovery of autologous bone graft - Sterile environment is not left

MARROW CELLUTION™ is an innovative instrument for the aspiration of bone marrow and cancellous bone.

MARROW CELLUTION™ enables aspiration of bone marrow with high cellular content

One puncture - multiple aspiration sites in the marrow space

INNOVATION

Reduces peripheral blood contamination - Closed system - Controlled movement of the cannula in the space

EFFICIENCY

Minimally invasive - One puncture - Many aspirates - Low aspirate volume - High cell yield - No centrifugation required

PERFORMANCE 

Higher CFU-f count per ml - Simultaneous recovery of autologous bone graft - Sterile environment is not left

SeraSeal TM supports and catalyzes the patient's own blood clotting during the formation of a blood clot and stops bleeding, without applying pressure, within 30 seconds.

SeraSeal TM contains inert agar polysaccharide/carbohydrate and bovine plasma-derived clotting factors.

How SeraSeal is used

SeraSeal is indicated for the control/stopping of hemorrhages (arterial and venous) of parenchymal organs, oozing hemorrhages, capillary hemorrhages, vascular anastomoses, etc., occurring in invasive, semi-invasive, and non-invasive procedures. SeraSeal is particularly applicable in surgical procedures.

How SeraSeal works

Blood clot formation is initiated by the release of tissue thromboplastin. This trigger initiates a series of reactions collectively known as the "coagulation cascade."

Proven effectiveness

The effectiveness of SeraSeal TM has been proven in several studies. Even in cases of difficult-to-control bleeding in the gastrointestinal tract, bleeding was completely stopped in 87% of patients using SeraSeal.

Dosage forms

SeraSeal 5 ml ampoule

SeraSeal 3 ml ampoule

SeraSeal 1.5 ml ampoule

Eye-Lotion Balanced salt solution - Rinsing solutions for safe and economical treatment during ophthalmic procedures

Application

Sterile irrigation solution for intraocular use during surgical procedures or for external moistening of the cornea

Proven manufacturing processes and the highest level of safety and reliability in the handling of pharmaceuticals and medical devices are the basic requirements for our ophthalmic irrigation solution

Properties

• Use of latex- and plasticizer-free product components
• Safe sterilization in accordance with the pharmacopoeia
• Tight in-process controls

VitaPES® dialyzers for the complex requirements of effective and safe treatment of chronic renal failure.

Properties

• Active surface (m²) - 2.1
• Packaging unit - 30 pcs.

Development

MTP Medical Technologies GmbH Pirna, as a subsidiary of Serumwerk Bernburg AG, has been developing and producing high-quality medical products for hemodialysis since 2007. In this specific case, 3 different dialyzers of the VitaPES® product line (Low, Balanced and High Flux) were developed. The outstanding performance properties of the Purema® hollow fiber membrane are based on the process innovation of pore-forming S.E.T. technology (Sieving Enhancing Technology). S.E.T. leads to a significant improvement in the separation properties of the membrane, which filters out harmful substances from the blood.

Technical innovation

The unprecedented performance characteristics of Purema® are based on the breakthrough process innovation of pore-forming S.E.T. technology (Sieving Enhancing Technology). The proprietary Sieving Enhancing Technology (S.E.T.) achieves membrane structures with significantly more uniform pore diameters and pore distribution than conventional synthetic membranes. S.E.T. thus leads to a significant improvement in the separation properties of the membrane.

Medical innovation

The properties of Purema® have been tailored to achieve both targeted elimination of agent molecules and improved clearance of low molecular weight uremic toxins. Dose and quality of dialysis treatment at the highest level together with perfect biocompatibility are important prerequisites to avoid immunological changes that may pose an increased risk to the patient.

In this way, optimal dialysis can help to

improve the patient's nutritional status prevent infections reduce the hospitalization rate improve the long-term survival rate.

Special trocar ground needle for implantable port catheter systems and drug pump systems.

Non-punching needle Special puncture cannulae for implanted port catheter systems made of medical steel with non-punching special ground joint, either with Luer lock attachment or optional connecting tube, handle or fixation wings.

Indications Via port catheter system continuous or intermittent supply of drugs, infusion solutions, blood transfusions, blood sampling, parenteral nutrition, pain therapy, central venous pressure measurement, etc.

Different diameters and stitch lengths are available depending on the application and necessary flow rate.

Advantages due to special grinding with trocar tip and lateral exit hole

• guarantees punch-free piercing of the silicone membrane
• prevents leakage and leaching of skin or silicone particles into the blood with subsequent complications
• reduces the risk of infection
• prolongs the function and service life of such systems
• stable trocar tip

Product information

SFN 1835 B        

Ø1.8 mm            

L=35 mm            

Gauge 15             

straight with Luer/Lock attachment (with tube)         

Packaging unit (PU) 25 pieces

Special trocar ground needle for implantable port catheter systems and drug pump systems.

Non-punching needle Special puncture cannulae for implanted port catheter systems made of medical steel with non-punching special ground joint, either with Luer lock attachment or optional connecting tube, handle or fixation wings.

Indications Via port catheter system continuous or intermittent supply of drugs, infusion solutions, blood transfusions, blood sampling, parenteral nutrition, pain therapy, central venous pressure measurement, etc.

Different diameters and stitch lengths are available depending on the application and necessary flow rate.

Advantages due to special grinding with trocar tip and lateral exit hole

• guarantees punch-free piercing of the silicone membrane
• prevents leakage and leaching of skin or silicone particles into the blood with subsequent complications
• reduces the risk of infection
• prolongs the function and service life of such systems
• stable trocar tip

Product information

SFN 1535 B        

Ø1.5 mm            

L=35 mm            

Gauge17             

straight with Luer/Lock connector (with tubing)         

Packaging unit (PU) 25 pieces

TITAN-PORT APH (extracorporeal apheresis) is a fully implantable titanium PORT system as an access device for performing extracorporeal apheresis.

The set includes

- port chambers with a self-sealing silicone membrane

- a single-lumen silicone catheter with a connection to the port chamber

- a screw to fix the catheter to the outflow tube

- a special puncture cannula, an introducer, a tunnelizer, instructions for use and a patient passport

In order to achieve the blood volume required for apheresis, appropriately large-volume cannulas are required, e.g. DPK 1835 and DPK 2035 or SFN 1535 G. These are distinguished by a special loop. These are characterized by a special grinding to avoid fragmentation of silicone particles and punching of a puncture channel in the membrane. A corresponding cannula is included with each system.

Product information

Description

Ø and length: 1.8 x 1200mm

sterile

working channel: 2.00mm

10 pieces per package

Description

Ø and length: 1.8 x 2300mm

working channel: 2.00mm

sterile

10 pieces per package

Description

Ø and length: 2,4 x 2300mm

sterile

Working channel: 2.80mm

10 pieces per package

VitaPES® dialyzers for the complex requirements of effective and safe treatment of chronic renal failure.

The excellent properties of our VitaPES® dialyzers, which have been confirmed in clinical practice, are the result of innovative product development and modern production technology.

Properties

• Highest quality of product components and their processing
• Gentle and environmentally friendly sterilization method
• Very good patient tolerability due to optimized biocompatibility
• High and stable clearance performance of the entire product range with different surfaces by using the patented membrane P.E.T. technology (Performance Enhancing Technology)
• Easy and safe handling in daily practice

VitaPES® dialyzers with excellent performance characteristics based on PUREMA membrane ensure excellent treatment of dialysis patients with high performance stability over the treatment period due to minimal immunological change and protein adsorption.

Product information

Ultrafiltration coefficient /ml/h/mmHg)              23

Surface area (m²)                                                              2.1

Filling volume (ml)                                                            119

VitaPES® dialyzers for the complex requirements of effective and safe treatment of chronic renal failure.

Properties

• Active surface (m²) - 1.5
• Packaging unit - 30 pcs.

Development

MTP Medical Technologies GmbH Pirna, as a subsidiary of Serumwerk Bernburg AG, has been developing and producing high-quality medical products for hemodialysis since 2007. In this specific case, 3 different dialyzers of the VitaPES® product line (Low, Balanced and High Flux) were developed. The outstanding performance characteristics of the Purema® hollow fiber membrane are based on the process innovation of pore-forming S.E.T. technology (Sieving Enhancing Technology). S.E.T. leads to a significant improvement in the separation properties of the membrane, which filters out harmful substances from the blood.

Technical innovation

The unprecedented performance characteristics of Purema® are based on the breakthrough process innovation of pore-forming S.E.T. technology (Sieving Enhancing Technology). The proprietary Sieving Enhancing Technology (S.E.T.) achieves membrane structures with significantly more uniform pore diameters and pore distribution than conventional synthetic membranes. S.E.T. thus leads to a significant improvement in the separation properties of the membrane.

Medical innovation

The properties of Purema® have been tailored to achieve both targeted elimination of agent molecules and improved clearance of low molecular weight uremic toxins. Dose and quality of dialysis treatment at the highest level together with perfect biocompatibility are important prerequisites to avoid immunological changes that may pose an increased risk to the patient.

In this way, optimal dialysis can help to

improve the patient's nutritional status prevent infections reduce the hospitalization rate improve the long-term survival rate.

VitaPES® dialyzers for the complex requirements of effective and safe treatment of chronic renal failure.

Properties

• Active surface (m²) - 1.7
• Packaging unit - 30 pcs.

Development

MTP Medical Technologies GmbH Pirna, as a subsidiary of Serumwerk Bernburg AG, has been developing and producing high-quality medical products for hemodialysis since 2007. In this specific case, 3 different dialyzers of the VitaPES® product line (Low, Balanced and High Flux) were developed. The outstanding performance characteristics of the Purema® hollow fiber membrane are based on the process innovation of pore-forming S.E.T. technology (Sieving Enhancing Technology). S.E.T. leads to a significant improvement in the separation properties of the membrane, which filters out harmful substances from the blood.

Technical innovation

The unprecedented performance characteristics of Purema® are based on the breakthrough process innovation of pore-forming S.E.T. technology (Sieving Enhancing Technology). The proprietary Sieving Enhancing Technology (S.E.T.) achieves membrane structures with significantly more uniform pore diameters and pore distribution than conventional synthetic membranes. S.E.T. thus leads to a significant improvement in the separation properties of the membrane.

Medical innovation

The properties of Purema® have been tailored to achieve both targeted elimination of agent molecules and improved clearance of low molecular weight uremic toxins. Dose and quality of dialysis treatment at the highest level together with perfect biocompatibility are important prerequisites to avoid immunological changes that may pose an increased risk to the patient.

In this way, optimal dialysis can help to

improve the patient's nutritional status prevent infections reduce the hospitalization rate improve the long-term survival rate.

VitaPES® dialyzers for the complex requirements of effective and safe treatment of chronic renal failure.

Properties

• Active surface (m²) - 1.9
• Packaging unit - 30 pcs.

Development

MTP Medical Technologies GmbH Pirna, as a subsidiary of Serumwerk Bernburg AG, has been developing and producing high-quality medical products for hemodialysis since 2007. In this specific case, 3 different dialyzers of the VitaPES® product line (Low, Balanced and High Flux) were developed. The outstanding performance characteristics of the Purema® hollow fiber membrane are based on the process innovation of pore-forming S.E.T. technology (Sieving Enhancing Technology). S.E.T. leads to a significant improvement in the separation properties of the membrane, which filters out harmful substances from the blood.

Technical innovation

The unprecedented performance characteristics of Purema® are based on the breakthrough process innovation of pore-forming S.E.T. technology (Sieving Enhancing Technology). The proprietary Sieving Enhancing Technology (S.E.T.) achieves membrane structures with significantly more uniform pore diameters and pore distribution than conventional synthetic membranes. S.E.T. thus leads to a significant improvement in the separation properties of the membrane.

Medical innovation

The properties of Purema® have been tailored to achieve both targeted elimination of agent molecules and improved clearance of low molecular weight uremic toxins. Dose and quality of dialysis treatment at the highest level together with perfect biocompatibility are important prerequisites to avoid immunological changes that may pose an increased risk to the patient.

In this way, optimal dialysis can help to

improve the patient's nutritional status prevent infections reduce the hospitalization rate improve the long-term survival rate.

The vertical range of manufacture and the manufacturing know-how of the production facility, the MPH company, which is part of the Serumwerk Bernburg group of companies, meets the highest quality standards. With an extensive range of system variants for all common dialysis machines, we offer our customers maximum flexibility and independence.

Features

• Optimum ergonomics and flawless bonding in the
• bloodline system ensure a safe dialysis process
• Individual testing (100% test) for leak tightness and pressure resistance of the products
• Various validated sterilization processes BETA/GAMMA and ETO
• All production steps are carried out according to GMP rules. During production, implementation of ISO 9001/EN 46001, ISO 9002/EN 46002, DIN EN ISO 13485 and DIN 1283 standards is guaranteed, as well as compliance with Council Directive No. 93/42/EEC on medical devices.

DiaCart and DiaBox bicarbonate cartridges for all common dialysis machines with suitable cartridge holder.

The bicarbonate cartridges represent a central component for the highest demands in the production of dialysis fluid.

The following technical requirements are offered by the extensive cartridge delivery program:

• Ergonomic design of the cartridge containers
• Use of high-quality starting materials in injection molding production
• Optimized packaging concept for storage and transport
• Environmentally friendly disposal due to uniform material fraction

DiaCart and DiaBox bicarbonate cartridges for all common dialysis machines with suitable cartridge holder.

The bicarbonate cartridges represent a central component for the highest demands in the production of dialysis fluid.

The following technical requirements are offered by the extensive cartridge delivery program:

• Ergonomic design of the cartridge containers
• Use of high-quality starting materials in injection molding production
• Optimized packaging concept for storage and transport
• Environmentally friendly disposal due to uniform material fraction

With citric acid as the acidifying agent, this is the first significant change in dialysate formulation in more than thirty years, moving away from traditional formulations containing acetic acid. It is cleared by the FDA for all patients and is used in many clinics around the world.

Patient Benefits:

• Replaces or reduces heparin requirements in CRF patients.
• Improves dialysis dose Kt/V
• Corrects acidosis
• Reduces post-dialysis bleeding
• Reduces dialysis-related inflammation

Product size

Citric acid 10 liter canister, 60 pieces per pallet (weight approx. 760 kg)

With citric acid as the acidifying agent, this is the first significant change in dialysate formulation in more than thirty years, moving away from traditional formulations containing acetic acid. It is cleared by the FDA for all patients and is used in many clinics around the world.

Patient Benefits:

• Replaces or reduces heparin requirements in CRF patients.
• Improves dialysis dose Kt/V
• Corrects acidosis
• Reduces post-dialysis bleeding
• Reduces dialysis-related inflammation

Product size

Citric acid 10 liter canister, 60 pieces per pallet (weight approx. 760 kg)

Basic set for large joints

An instrument for arthroscopic debridement of chondral lesions.

The new tool allows maintaining a vertical section of the shoulder of the chondral lesion anywhere in human joints using an arthroscopic approach.

Proper chondrectomy is critical prior to both bone marrow stimulation and implantation of matrices, as well as AMIC, MACI and other bioimplants.

A perfect condylar chondrectomy 

Simply insert the chondrectome into the correct arthoscopic portal near the chondral defect.

Instruments

• Anterior chondrectome 90°, F
• Parallel chondrectome 30°, P
• Right-sided chondrectome, SR
• Left-sided chondrectome, SL
• Sterilization mat
• Container for instruments

Application

Chondrectomes allow easy separation of damaged and calcified cartilage layer from the subchondral surface, at the same time the subchondral plate remains intact. The unique shape of the chondrectomes and special formation of the cutting edge allow precise modeling of the cartilage lesions and formation of vertical walls on the defect.

The tools can be used in any anatomical situation (from any approach direction) and open or arthroscopically.

Special trocar ground needle for implantable port catheter systems and drug pump systems.

Non-punching needle Special puncture cannulae for implanted port catheter systems made of medical steel with non-punching special ground joint, either with Luer lock attachment or optional connecting tube, handle or fixation wings.

Indications Via port catheter system continuous or intermittent supply of drugs, infusion solutions, blood transfusions, blood sampling, parenteral nutrition, pain therapy, central venous pressure measurement, etc.

Different diameters and stitch lengths are available depending on the application and necessary flow rate.

Advantages due to special grinding with trocar tip and lateral exit hole

• guarantees punch-free piercing of the silicone membrane
• prevents leakage and leaching of skin or silicone particles into the blood with subsequent complications
• reduces the risk of infection
• prolongs the function and service life of such systems
• stable trocar tip

Product information

DPK 2035         

Ø 2,0 mm                

L=35 mm                

Gauge 14             

with Mandarin + Needle Free Adapter   

Packaging unit (PU) 25 pieces

Special trocar ground needle for implantable port catheter systems and drug pump systems.

Non-punching needle Special puncture cannulae for implanted port catheter systems made of medical steel with non-punching special ground joint, either with Luer lock attachment or optional connecting tube, handle or fixation wings.

Indications Via port catheter system continuous or intermittent supply of drugs, infusion solutions, blood transfusions, blood sampling, parenteral nutrition, pain therapy, central venous pressure measurement, etc.

Different diameters and stitch lengths are available depending on the application and necessary flow rate.

Advantages due to special grinding with trocar tip and lateral exit hole

• guarantees punch-free piercing of the silicone membrane
• prevents leakage and leaching of skin or silicone particles into the blood with subsequent complications
• reduces the risk of infection
• prolongs the function and service life of such systems
• stable trocar tip

Product information

SFN 0930 B          

Ø 0,9mm                

L=30mm                

Gauge 20             

straight with Luer/Lock connector (with tubing)

Packaging unit (PU) 25 pieces

TITAN-PORT D (Dialysis) is a fully implantable titanium PORT system as an access device for performing veno-venous dialysis.

Product information

Depending on the product, the set contains

• one or two suitable port chambers with self-sealing silicone membrane and the respective matching port catheter
• screws for fixation
• suitable special puncture cannulas, introducer set, tunnelizer, instructions for use and patient passport

In order to achieve the blood flow rate required for dialysis purposes, appropriately large-volume cannulas are required, e.g. DPK 1835 and DPK 2035. These are characterized by a special grinding to prevent fragmentation of silicone particles and punching out of a puncture channel in the membrane. Suitable cannulas are included with each system.

An instrument for arthroscopic debridement of chondral lesions.

The new tool allows maintaining a vertical section of the shoulder of the chondral lesion anywhere in human joints using an arthroscopic approach.

Proper chondrectomy is critical prior to both bone marrow stimulation and implantation of matrices, as well as AMIC, MACI and other bioimplants.

A perfect condylar chondrectomy 

Simply insert the chondrectome into the correct arthoscopic portal near the chondral defect.

Instruments

• Anterior chondrectome 90°, F
• Parallel chondrectome 30°, P
• Right-sided chondrectome, SR
• Left-sided chondrectome, SL
• Sterilization mat
• Container for instruments

Additional instruments:

• Semi-tubular guide I

The half-tube guide helps to insert the bioimplant into the joint cavity through the outer body layer. In addition, it provides pressure equalization during dry arthroscopy.

• Bio Implant-Inserter

The Bio Implant Inserter enables the insertion of bioimplants into the joint cavity via an arthroscopic portal using a half-tube guide.

• Plate wound spreader 30mm

A plate wound spreader is used to expose the joint capsule including soft tissue, thus creating the necessary working space within the joint cavity during dry arthroscopy. Exposure is achieved by means of a thread pulled through the skin and connected to the plate wound retractor.

• Curved raspatory (8)

The curved raspatory is used to compress matrix or bone marrow at the site of the defect and finally to sculpt the surface.

• Bone marrow guide 10/60° with loader

The bone marrow guide (inserter) is used to implant bone marrow into the bone cyst or at the site of the defect. The tool enables compaction of the bone marrow during implantation. The bone marrow guide consists of a cylinder, a pusher and a loader.

Application

Chondrectomes allow easy separation of the damaged and calcified cartilage layer from the subchondral surface, while leaving the subchondral plate intact. The unique shape of the chondrectomes and special formation of the cutting edge allow precise modeling of the cartilage lesions and formation of vertical walls on the defect.

The tools can be used in any anatomical situation (from any approach direction) and open or arthroscopically.

Basic set for small joints

An instrument for arthroscopic debridement of chondral lesions.

The new tool allows maintaining a vertical section of the shoulder of the chondral lesion anywhere in human joints using an arthroscopic approach.

Proper chondrectomy is critical prior to both bone marrow stimulation and implantation of matrices, as well as AMIC, MACI and other bioimplants.

A perfect condylar chondrectomy 

Simply insert the chondrectome into the correct arthoscopic portal near the chondral defect.

Instruments

• Small anterior chondrectome 90°, F
• Small round chondrectome, sC
• Small right-sided chondrectome, sR
• Small left-sided chondrectome, sL
• Sterilization mat
• Container for instruments

Application

Chondrectomes allow easy separation of damaged and calcified cartilage layer from the subchondral surface, at the same time the subchondral plate remains intact. The unique shape of the chondrectomes and special formation of the cutting edge allow precise modeling of the cartilage lesions and formation of vertical walls on the defect.

The tools can be used in any anatomical situation (from any approach direction) and open or arthroscopically.

An instrument for arthroscopic debridement of chondral lesions.

The new tool allows maintaining a vertical section of the shoulder of the chondral lesion anywhere in human joints using an arthroscopic approach.

Proper chondrectomy is critical prior to both bone marrow stimulation and implantation of matrices, as well as AMIC, MACI and other bioimplants.

A perfect condylar chondrectomy 

Simply insert the chondrectome into the correct arthoscopic portal near the chondral defect.

Instruments

• Small anterior chondrectome 90°, F
• Small round chondrectome, sC
• Small right-sided chondrectome, sR
• Small left-sided chondrectome, sL
• Sterilization mat
• Container for instruments

Additional instruments:

• Semi-tubular guide II

The half-tube guide helps to insert the bioimplant into the joint cavity through the outer body layer. In addition, it provides pressure equalization during dry arthroscopy.

• Arthroscopic hook Ø1.5x3.5/60°

FFB833

• Plate wound spreader 20mm

A plate wound retractor is used to expose the joint capsule including soft tissue, thus creating the necessary working space within the joint cavity during dry arthroscopy. Exposure is achieved by means of a thread pulled through the skin and connected to the plate wound retractor.

• Curved raspatory (5)

The curved raspatory is used to compress matrix or bone marrow at the site of the defect and finally to sculpt the surface.

• Bone marrow guide 6/60° with loader

The bone marrow guide (inserter) is used to implant bone marrow into the bone cyst or at the site of the defect. The tool enables compaction of the bone marrow during implantation. The bone marrow guide consists of a cylinder, a pusher and a loader.

Application

Chondrectomes allow easy separation of the damaged and calcified cartilage layer from the subchondral surface, while leaving the subchondral plate intact. The unique shape of the chondrectomes and special formation of the cutting edge allow precise modeling of the cartilage lesions and formation of vertical walls on the defect.

The tools can be used in any anatomical situation (from any approach direction) and open or arthroscopically.

Especially for blood sampling, transfusion, contrast medium injection*, apheresis and high pressure injection.

SFN 1320 S - Features

Ø/mm -  1.3

L/mm – 20

Gauge - 22

Punch-free needle

• guarantees punch-free piercing of the silicone membrane
• prevents leakage and leaching of skin or silicone particles into the blood with subsequent complications
• reduces the risk of infection
• prolongs the function and service life of such systems
• facilitates and improves handling due to fixation wings
• connection tube made of PU (polyurethane) with Luer-Lock attachment (taxol compatible, latex and PVC free)
• stable trocar tip
• Protection against needlestick injuries (complies with TRBA 250)
• Easy folding of the protective cap until it clicks into place

A 3-layer medical face mask with integrated nose clip for maximum user comfort. 

Description

• 3-layer fleece for best possible effect
• Moldable nose clip that comfortably fits any face shape
• Ear loops
• Size: 9.5*17.5cm
• Weight: 3.5g ±0.2g
• Color: Blue

The PCL Spit Rapid Spit Test is an in vitro diagnostic medical device based on a rapid immunochromatographic assay (ICA) procedure and is designed for the qualitative detection of SARS-CoV-2 antigens in human saliva specimens.

Available in the following packaging units:

1 pc. Pack, 5 pcs. Pack and 50 pcs. Pack

Specimen collection

1. The person being tested collects saliva near the tip of the tongue (approximately 0.5 mL) for 30 seconds with the mouth closed.

2. Spit the collected saliva directly into the tube with extraction buffer for immediate use. The funnel attachment can be used to assist in this process. The addition of saliva should approximately double the volume contained in the tube.

3. Close the tube tightly with the filter cap. Mix the contents by turning it upside down 10 times. (Open test card pouch immediately before use. Failure to use the pouch immediately after opening may affect the accuracy of the results).

4. Open test card pouch and place test card on a flat surface. Add a few drops of the mixture of saliva sample and extraction buffer to the application position of the Test Card. The application opening should be almost completely filled. Always use at least 2-3 drops.

5. Read the result after 10 minutes.

The PCL Spit Rapid Spit Test is an in vitro diagnostic medical device based on a rapid immunochromatographic assay (ICA) procedure and is designed for the qualitative detection of SARS-CoV-2 antigens in human saliva specimens.

Available in the following packaging units:

1 pc. Pack, 5 pcs. Pack and 50 pcs. Pack

Specimen collection

1. The person being tested collects saliva near the tip of the tongue (approximately 0.5 mL) for 30 seconds with the mouth closed.

2. Spit the collected saliva directly into the tube with extraction buffer for immediate use. The funnel attachment can be used to assist in this process. The addition of saliva should approximately double the volume contained in the tube.

3. Close the tube tightly with the filter cap. Mix the contents by turning it upside down 10 times. (Open test card pouch immediately before use. Failure to use the pouch immediately after opening may affect the accuracy of the results).

4. Open test card pouch and place test card on a flat surface. Add a few drops of the mixture of saliva sample and extraction buffer to the application position of the Test Card. The application opening should be almost completely filled. Always use at least 2-3 drops.

5. Read the result after 10 minutes.

High quality self and external protection, good wearing comfort, high breathability due to high quality fleece materials and extra strong and flexible nose clip

CE MARKING - NB 2163

Product details

Name: Respirator, FFP2 without valve Type: YY0525 Category: PPE category III Equipment class: FFP2 NR (Non Reusable) Quantity/packing unit: Individually packed, in 25 pieces package Color: White Storage conditions: Do not store below 0°C or above 40°C and in a dry place without direct sunlight Size Mask:16x11cm when folded (Slight variations in size possible) Weight (per mask): approx. 6.00g (Slight variations possible) Certification: EN 149:2001+A1:2009, Declaration of Conformity (EU 2016/425)

Instructions for use

Minimum durability: see mask

For use according to PPE regulation

It is recommended to take off and change the respirator every 4 hours or in case of moisture penetration

Not reusable

These high quality HY9320 FFP2 respirators offer 94% filtration against harmful particles, combine a lightweight design and certified safety to provide safe and comfortable respiratory protection.

Designed with comfort and safety in mind, these disposable respirators provide a tight seal thanks to their adjustable nose bridge. The elastic strap is held in place by sturdy plastic clips to ensure the mask is secure at all times. Supplied in a box of 20 pieces.

Description

• Complies with EN149: 2001 + A1: 2009
• FFP2 mask with an assigned protection factor of 10
• Latex free head harness for maximum protection
• No exposure of metal parts
• Folds flat for easy storage
• Stays securely on face
• Individually packaged for hygienic reasons
• Adjustable nose clip 
• Soft inner nose foam for added comfort                                            
• Box of 20 pieces

These certified, particle-filtering half masks FFP2 for self and external protection against particles, droplets as well as solid or liquid aerosols are certified according to the standard EN 149:2001 + A1:2009 and belong to PPE (Personal Protective Equipment) Class III.

Thus, the masks comply with EN 149:2001+A1:2009 according to the PPE Regulation (EU) 2016/425.

CE- certification available!

Product features

• FFP2 test center number 2834, EN149:2001+A1:2009 FFP2 NR
• Pleasant and intelligible speech due to forward facing mask volume
• Slower wetting due to appropriate distance to the mouth
• Particularly comfortable to wear due to very high quality workmanship and soft straps
• Individually adjustable clip for the nose area with pleasant foam seal in the nose clip
• Adjustable ear bands, elastic rubber band
• Well suited for spectacle wearers thanks to easy adjustment to the face
• One size fits all for adults
• particle filtering respirator half masks without valve
• Folding mask
• White color
• Adjustable nose clip for maximum comfort and seal
• Latex free and nikel free
• Dispensing information: 1 carton contains 40 pieces of 2 packed in a bag

Product information

Item weight: 0.18 grams

Package dimensions: 18.9 x 14.3 x 13.7 cm; 400 grams

For the flat folded mask, the width is about 11 cm and the long vertical side is about 16 cm.

The height of a mask double pack is about 1.5 cm.

These respirators HY9330 FFP3 have a unique three-piece design and combine comfort, protection and functionality. They allow for plenty of movement while maintaining safety and are designed to prevent slipping.

These high quality HY9330 FFP3 respirators combine a lightweight design and certified safety to provide safe and comfortable respiratory protection. They are ideal as medical personal protective equipment for primary and ambulatory patients, as well as in community and social service settings. 

Description

• Complies with EN149: 2001 + A1: 2009
• FFP3 for protection against infectious respiratory diseases and bacteria
• Latex free head harness 
• No exposure of metal parts
• Stays securely on the face
• Individually packaged for hygienic reasons
• Adjustable nose clip 
• Soft inner nose foam for added comfort
• Compatible with other PPE
• Box of 20 pieces

Packaging Description

HYGIENIC PACKAGING: Protects the respirator from contamination before use, also allows convenient storage and dispensing in the workplace.

This disposable multi-layer surgical quality face mask is ideal for professional or personal use!

Thanks to the deformable nosepiece and stretchable elastics, it fits both men and women and can be ideally adapted to any face.

Approved according to EN 14683 

Description

NOSE CLIP: The integrated nose clip allows for an ideal fit to any face shape and, together with the elastic band, enhances both safety and the user's wearing experience

STANDARD QUALITY: Approved according to EN 14683 (medical face masks), AC (type IIR)!

MULTI-LAYER: The double layer material of our face mask increases the safety. Please wear the mask to completely cover your nose and mouth to reduce the spread of droplets

SPACE SAVING: The Kingfa MNS is extra flat for easy storage in any pants pocket or handbag. Ideal as a spare, to take with you and as a display for customers / visitors!

Package dimensions: 19 x 10 x 8 cm - 150grams

The FFP2 mask can be fastened with ear loops and offers a secure fit. It ensures a very high level of protection for the wearer, but also for the person in front of him.

Since the KINGFA KF-A F10 mask does not have a valve, it filters the exhaled as well as the inhaled air according to the EN 149 standard. Furthermore, the mask complies with the EU regulation 2016/425 and is thus a product of the Personal Protective Equipment category III (PPE).

Product data

• FFP2 mask with ear loops
• 6 pieces individually packed in a box
• (PPE) Personal protective equipment category III
• EN 149:2001 + A1:2009 (FFP2 NR)
• complies with EU regulation 2016/425
• Protection class: FFP2
• Filtering efficiency ≥ 94%
• 5-layer
• without exhalation valve
• Material: non-woven fabric with nose clip
• easy handling for everyday use
• high wearing comfort and secure fit
• KINGFA KF-A F10(SC)

The 5-layer, filtering mouth and nose protection is characterized by the pleasant, with adjustable nose wing easily adjustable fit and high wearing comfort.

The protective masks of FFP3 quality, protect against bacteria, and germs! Thanks to the existing rubber bands (head), the mask sits firmly without slipping off.

Product data

• 30 x FFP3 NR - respirator mask
• according to standard EN149:2001+A1:2009 with CE2163 number
• For single use
• Material: Non-woven
• Color: White
• Protects mouth and nose area
• Protection class FFP3
• 5-layer filter structure
• Layer by layer filtration
• Weight: 6,6g / mask
• Elastic rubber band
• low exhalation resistance for high wearing comfort!

Graft: Achilles

Description

• w/ Bone Block
• Length: ≥ 14 cm
• Frozen
• Sterile

Graft: Patellar Ligament

Description

• Whole
• Frozen
• Sterile

Graft: Tibialis Anteroir

Description: Double Strand

• Length: 23.5 cm
• Folder D*: 7.5 mm min
• Frozen
• Sterile

Description

• AlloPac® - rinsed
• Particle size: 1 - 4 mm cortical particle size
• Particle size: 1 - 9.5 mm cancellous particle size
• Volume: 25 cc
• Frozen
• Sterile

Graft: Peroneus Longus

Description

• Double Strand
• Length: ≤ 23 cm
• Folder D*: 7.5 mm min.
• Frozen
• Sterile

Description

• AlloPac® - rinsed
• Particle size: 1 - 4 mm cortical particle size
• Particle size: 1 - 9.5 mm cancellous particle size
• Volume: 50 cc
• Frozen
• Sterile

Description

• AlloPac® - rinsed
• Particle size: 1 - 4 mm cortical particle size
• Particle size: 1 - 9.5 mm cancellous particle size
• Volume: 100 cc
• Frozen
• Sterile

Description

• Cancellous bone chips (~4-9.5 mm particle size)
• Particle size: 4-9.5 mm
• Volume: 15 cc
• Freeze-dried
• Sterile
• Requires moisture

Description

• Cancellous bone chips (~4-9.5 mm particle size)
• Particle size: 4-9.5 mm
• Volume: 30 cc
• Freeze-dried
• Sterile
• Requires moisture

Description

• Cancellous bone chips (~4-9.5 mm particle size)
• Particle size: 4-9.5 mm
• Volume: 60 cc
• Freeze-dried
• Sterile
• Requires moisture

Description

• Cancellous bone chips (~4-9.5 mm particle size)
• Particle size: 4-9.5 mm
• Volume: 90 cc
• Freeze-dried
• Sterile
• Requires moisture

Description

• Cancellous bone chips (1-9.5 mm particle size)
• Particle size: 1-9.5 mm
• Volume: 15 cc
• Freeze-dried
• Sterile
• Requires moisture

Description

• Cancellous bone chips (1-9.5 mm particle size)
• Particle size: 1-9.5 mm
• Volume: 30 cc
• Freeze-dried
• Sterile
• Requires moisture

Description

• Cancellous bone chips (1-9.5 mm particle size)
• Particle size: 1-9.5 mm
• Volume: 50 cc
• Freeze-dried
• Sterile
• Requires moisture

Description

• Cancellous bone chips (1-9.5 mm particle size)
• Particle size: 1-9.5 mm
• Volume: 90 cc
• Freeze-dried
• Sterile
• Requires moisture

Description

• Crushed cancellous bone (~1-4 mm particle size)
• Particle size: ~1-4 mm
• Volume: 15 cc
• Freeze-dried
• Sterile
• Requires moisture

Description

• Crushed cancellous bone (~1-4 mm particle size)
• Particle size: ~1-4 mm
• Volume: 30 cc
• Freeze-dried
• Sterile
• Requires moisture

Description

• Crushed cancellous bone (~1-4 mm particle size)
• Particle size: ~1-4 mm
• Volume: 60 cc
• Freeze-dried
• Sterile
• Requires moisture

Description

• Cancellous bone cube (~1 cm³ particle size)
• Particle size: 1 cm³
• Volume: 15 cc
• Freeze-dried
• Sterile
• Requires moisture
• All sizes allowed for +3/ -0 cubes

Description

• Cancellous bone cube (~1 cm³ particle size)
• Particle size: 1 cm³
• Volume: 15 cc
• Freeze-dried
• Sterile
• Requires moisture
• All sizes allowed for +3/ -0 cubes

Description

• Cancellous bone block
• Length: 3.0 cm
• Width: 1.5 cm
• Height: 1,5 cm
• Freeze-dried
• Sterile
• Requires moisture

Description

• Cortical/ Cancellous bone chips (~1-9.5mm particle size)
• Particle size: 1-9.5mm
• Volume: 15 cc
• Freeze-dried
• Sterile
• Requires moisture
• Volume ratio is 1:4 cortical:cancellous bone

Description

• Cortical/ Cancellous bone chips (~1-9.5mm particle size)
• Particle size: 1-9.5mm
• Volume: 30 cc
• Freeze-dried
• Sterile
• Requires moisture
• Volume ratio is 1:4 cortical:cancellous bone

Description

• Femur heads
• Diameter: ≥ 4.7 cm
• Sterile
• Frozen

Description

• Femur heads
• Diameter: ≥ 4.8 cm
• Sterile
• Frozen

Description

• AlloFuse cortical fibers
• Demineralized Bone Fibers (DBF™)* Technology.
• Volume: 1 cc
• Sterile
• PKG: Saline Solution

Description

• AlloFuse cortical fibers
• Demineralized Bone Fibers (DBF™)* Technology.
• Volume: 5 cc
• Sterile
• PKG: Saline Solution

Description

• AlloFuse cortical fibers
• Demineralized Bone Fibers (DBF™)* Technology.
• Volume: 10 cc
• Sterile
• PKG: Saline Solution

Description

• AlloFuse Fiber Boat
• Demineralized Bone Fiber (DBF™)* Technology.
• Size: Small
• Length: 50 mm
• Width: 25 mm
• Height: 6 mm
• Volume: 5 cc
• Sterile
• *DBF is a trademark of TheraCell, Inc.

Description

• AlloFuse Fiber Boat
• Demineralized Bone Fiber (DBF™)* Technology.
• Size: Large
• Length: 100 mm
• Width: 25 mm
• Height: 6 mm
• Volume: 10 cc
• Sterile
• *DBF is a trademark of TheraCell, Inc.

Description

• AlloFlex Filler (1-4 mm particle size)
• Partially demineralized cancellous bone
• Particle size: 1-4 mm
• Volume: 2.5 cc
• Freeze-dried
• Sterile
• Requires moisture

Description

• AlloFlex Filler (1-4 mm particle size)
• Partially demineralized cancellous bone
• Particle size: 1-4 mm
• Volume: 5 cc
• Freeze-dried
• Sterile
• Requires moisture

Description

• AlloFlex Filler (1-4 mm particle size)
• Partially demineralized cancellous bone
• Particle size: 1-4 mm
• Volume: 10 cc
• Freeze-dried
• Sterile
• Requires moisture

Description

• AlloFuse DBM Putty
• Demineralized bone matrix (DBM)
• Volume: 1 cc
• Ambient
• Sterile

Description

• AlloFuse DBM Putty
• Demineralized bone matrix (DBM)
• Volume: 2.5 cc
• Ambient
• Sterile

Description

• AlloFuse DBM Putty
• Demineralized bone matrix (DBM)
• Volume: 5 cc
• Ambient
• Sterile

Description

• AlloFuse DBM Kitt
• Demineralized bone matrix with cancellous bone (DBMs)
• Volume: 10 cc
• Ambient
• Sterile

Description

• AlloFuse Plus DBM Paste
• Demineralized bone matrix with cancellous bone
• Volume: 1 cc
• Ambient
• Sterile

Description

• AlloFuse Plus DBM Paste
• Demineralized bone matrix with cancellous bone
• Volume: 3 cc
• Ambient
• Sterile

Description

• AlloFuse Plus DBM Paste
• Demineralized bone matrix with cancellous bone
• Volume: 8 cc
• Ambient
• Sterile

Description

• AlloGro® DBM (125-710 micrometer particle size)
• Demineralized bone matrix (DBM)
• Particle size: 125-710 microns
• Volume: 10 cc
• Freeze-dried
• Sterile
• Requires moisture

Microfracturing is increasingly criticized as a treatment option for focal cartilage defects and, according to professional societies and cartilage experts, should only be used in exceptional cases. Nanofracturing offers an effective alternative for the treatment of chondral and osteochondral defects. NanoFx® is a bone marrow stimulation system that provides a standardized procedure for nanofracturing. Deep perforation of the subchondral plate and sub-articular cancellous bone creates direct access channels into the medullary canal through which mesenchymal stem cells (MSCs) can infiltrate into the cartilage defect. This bleeding in with accompanying recruitment of MSC is a prerequisite for cartilage regeneration. Due to the 9 mm deep perforation using NanoFx®, high yields of MSC can be achieved, promoting high-quality cartilage regeneration with a hyaline-like character. In addition, due to the 1 mm thin diameter, the subchondral plate and cancellous bone are spared, with the aim of promoting rapid healing and restoration of the subchondral bone.

ADVANTAGES OF NANOFRACTURING

• STANDARDIZED PROCEDURE
• Controlled depth of 9 mm and narrow diameter of 1 mm
• Reusable instrument with sharp disposable needles

• SUPERIOR BONE MARROW STIMULATION
• Increased stem cell yield due to deeper perforation
• Better defect filling with high collagen type 2 content

• EASY AND SAFE APPLICATION
• Smooth and fast perforation
• Facilitates restoration of subchondral bone

NANOFX^® AND HYALOFAST^®

CONVINCING ONE-STEP CARTILAGE REGENERATION WITH THE COMBINATION OF NANOFX® AND HYALOFAST®

NanoFx® and Hyalofast® offer a modern therapeutic concept for the treatment of chondral and osteochondral defects. Nanofracturing is a standardized procedure for the recruitment of mesenchymal stem cells (MSC) from the medullary canal. Matrix augmented cartilage regeneration with Hyalofast® promotes MSC differentiation to support chondrogenesis through the biological activity of hyaluronic acid. Thus, NanoFx® and Hyalofast® complement each other to form an optimal therapeutic concept for the treatment of cartilage defects.

FAST AND EASY APPLICATION

The NanoFx® Guide can be inserted into the defect arthroscopically or minimally invasively and requires no specific incisions. With the sterile disposable needle, a sharp instrument is always at hand to perforate the subchondral plate. NanoFx® is easy to put together and therefore quickly ready for use. Compared to microfracturing, the force of the hammer blow is optimally transferred to the 1 mm thin tip of the needle, so that even light blows are sufficient. Due to the integrated depth limitation, the needle is always inserted into the cancellous bone to a depth of 9 mm in a controlled manner.

Application of NanoFx®:

Step 1:

Insert the PleuriStik needle, tip down, through the opening of the Thumb Tab and through the proximal opening of the NanoFX® Guide without the needle being visible at the distal tip of the guide.

Step 2:

Place the tip of the NanoFx® Guide 2-3 mm in front of the intact cartilage wall away into the defect. Place the tip of the NanoFX® Guide only lightly on the subchondral plate.

Step 3:

Lightly tap the exposed proximal tip of the needle several times with a hammer to insert the needle into the defect to the depth limit of 9mm.

Step 4:

To retract the needle one-handed, press down on the thumb tab with your thumb. This will lever the PleuriStik needle out of the NanoFx® Guide. To perform additional perforations, reposition the guide and repeat steps 2-4.

The NanoFx® Guide is reusable and must be cleaned and sterilized after use.

NANOFX® SHORT AND COMPACT

Product: NanoFx® - Instrument for bone marrow stimulation Article: NanoFx® Guide, PleuriStik Nitinol needle, Thumb Tab Approval: medical device with CE mark Sterilization: gamma sterilized Storage: store in a dry place

DEVELOPMENT OF NANOFRACTURING

Bone marrow stimulation to recruit progenitor cells into the cartilage defect is a well-established therapeutic option in cartilage regeneration. Since the late 1980s, microfracturing emerged as the primary treatment choice because of its low cost, relatively low morbidity, and encouraging results as an initial procedure for cartilage defects, especially in young and active patients (1-3).

Renewed interest in the effects on subchondral bone shed new light on the limitations of microfracturing: shallow channels, wall compression, and an increase in trabecular wall thickness and density were observed computed tomographically and histologically (4-6). Chen et al. reported that deeper subchondral bone marrow stimulation resulted in improved cartilage defect filling, more type 2 collagen, and less type 1 collagen than shallow bone marrow access (5).

A study by Eldracher et al (7), showed that 1 mm thin holes had improved histo- gy, cancellous bone restoration, and immunoreactivity to type 2 collagen compared to 1.8 mm wide holes.

The nonstandard depth, diameter, and perforation density of microfracturing led to the development of a new method to perforate the subchondral plate (nanofracturing), which has a standardized depth of 9 mm and a diameter of 1 mm.

LITERATURE

Kreuz PC, Steinwachs MR, Erggelet C, Krause SJ, Konrad G, Uhl M, Südkamp N. Results after microfracture of full-thickness chondral defects in different compartments in the knee. Osteoarthritis Cartilage. 2006 Nov;14(11):1119-25.

Mithoefer K, Williams RJ 3rd, Warren RF, Potter HG, Spock CR, Jones EC, Wickiewicz TL, Marx RG. The microfracture technique for the treatment of articular cartilage lesions in the knee. A prospective cohort study. J Bone Joint Surg Am. 2005 Sep;87(9):1911-20.

Steadman JR, Briggs KK, Rodrigo JJ, Kocher MS, Gill TJ, Rodkey WG. Outcomes of microfracture for traumatic chondral defects of the knee: average 11-year follow-up. Arthroscopy. 2003 May-Jun;19(5):477-84.

Chen H, Sun J, Hoemann CD, Lascau-Coman V, Ouyang W, McKee MD, Shive MS, Buschmann MD. Drilling and microfracture lead to different bone structure and necrosis during bone-marrow stimulation for cartilage repair. J Orthop Res. 2009 Nov;27(11):1432-8.

Chen H, Hoemann CD, Sun J, Chevrier A, McKee MD, Shive MS, Hurtig M, Buschmann MD. Depth of subchondral perforation influences the outcome of bone marrow stimulation cartilage repair. J Orthop Res. 2011 Aug;29(8):1178-84.

Fortier LA, Cole BJ, McIlwraith CW. Science and animal models of marrow stimulation for cartilage repair. J Knee Surg. 2012 Mar;25(1):3-8.

Eldracher M. et al. Small Subchondral Drill Holes improve Marrow Stimulation of Articular Cartilage Defects. Am J Sports Med. 2014 Nov;42(11):2741-50.

Microfracturing is increasingly criticized as a treatment option for focal cartilage defects and, according to professional societies and cartilage experts, should only be used in exceptional cases. Nanofracturing offers an effective alternative for the treatment of chondral and osteochondral defects. NanoFx® is a bone marrow stimulation system that provides a standardized procedure for nanofracturing. Deep perforation of the subchondral plate and sub-articular cancellous bone creates direct access channels into the medullary canal through which mesenchymal stem cells (MSCs) can infiltrate into the cartilage defect. This bleeding in with accompanying recruitment of MSC is a prerequisite for cartilage regeneration. Due to the 9 mm deep perforation using NanoFx®, high yields of MSC can be achieved, promoting high-quality cartilage regeneration with a hyaline-like character. In addition, due to the 1 mm thin diameter, the subchondral plate and cancellous bone are spared, with the aim of promoting rapid healing and restoration of the subchondral bone.

ADVANTAGES OF NANOFRACTURING

• STANDARDIZED PROCEDURE
• Controlled depth of 9 mm and narrow diameter of 1 mm
• Reusable instrument with sharp disposable needles

• SUPERIOR BONE MARROW STIMULATION
• Increased stem cell yield due to deeper perforation
• Better defect filling with high collagen type 2 content

• EASY AND SAFE APPLICATION
• Smooth and fast perforation
• Facilitates restoration of subchondral bone

NANOFX^® AND HYALOFAST^®

CONVINCING ONE-STEP CARTILAGE REGENERATION WITH THE COMBINATION OF NANOFX® AND HYALOFAST®

NanoFx® and Hyalofast® offer a modern therapeutic concept for the treatment of chondral and osteochondral defects. Nanofracturing is a standardized procedure for the recruitment of mesenchymal stem cells (MSC) from the medullary canal. Matrix augmented cartilage regeneration with Hyalofast® promotes MSC differentiation to support chondrogenesis through the biological activity of hyaluronic acid. Thus, NanoFx® and Hyalofast® complement each other to form an optimal therapeutic concept for the treatment of cartilage defects.

FAST AND EASY APPLICATION

The NanoFx® Guide can be inserted into the defect arthroscopically or minimally invasively and requires no specific incisions. With the sterile disposable needle, a sharp instrument is always at hand to perforate the subchondral plate. NanoFx® is easy to put together and therefore quickly ready for use. Compared to microfracturing, the force of the hammer blow is optimally transferred to the 1 mm thin tip of the needle, so that even light blows are sufficient. Due to the integrated depth limitation, the needle is always inserted into the cancellous bone to a depth of 9 mm in a controlled manner.

Application of NanoFx®:

Step 1:

Insert the PleuriStik needle, tip down, through the opening of the Thumb Tab and through the proximal opening of the NanoFX® Guide without the needle being visible at the distal tip of the guide.

Step 2:

Place the tip of the NanoFx® Guide 2-3 mm in front of the intact cartilage wall away into the defect. Place the tip of the NanoFX® Guide only lightly on the subchondral plate.

Step 3:

Lightly tap the exposed proximal tip of the needle several times with a hammer to insert the needle into the defect to the depth limit of 9mm.

Step 4:

To retract the needle one-handed, press down on the thumb tab with your thumb. This will lever the PleuriStik needle out of the NanoFx® Guide. To perform additional perforations, reposition the guide and repeat steps 2-4.

The NanoFx® Guide is reusable and must be cleaned and sterilized after use.

NANOFX® SHORT AND COMPACT

Product: NanoFx® - Instrument for bone marrow stimulation Article: NanoFx® Guide, PleuriStik Nitinol needle, Thumb Tab Approval: medical device with CE mark Sterilization: gamma sterilized Storage: store in a dry place

DEVELOPMENT OF NANOFRACTURING

Bone marrow stimulation to recruit progenitor cells into the cartilage defect is a well-established therapeutic option in cartilage regeneration. Since the late 1980s, microfracturing emerged as the primary treatment choice because of its low cost, relatively low morbidity, and encouraging results as an initial procedure for cartilage defects, especially in young and active patients (1-3).

Renewed interest in the effects on subchondral bone shed new light on the limitations of microfracturing: shallow channels, wall compression, and an increase in trabecular wall thickness and density were observed computed tomographically and histologically (4-6). Chen et al. reported that deeper subchondral bone marrow stimulation resulted in improved cartilage defect filling, more type 2 collagen, and less type 1 collagen than shallow bone marrow access (5).

A study by Eldracher et al (7), showed that 1 mm thin holes had improved histo- gy, cancellous bone restoration, and immunoreactivity to type 2 collagen compared to 1.8 mm wide holes.

The nonstandard depth, diameter, and perforation density of microfracturing led to the development of a new method to perforate the subchondral plate (nanofracturing), which has a standardized depth of 9 mm and a diameter of 1 mm.

LITERATURE

Kreuz PC, Steinwachs MR, Erggelet C, Krause SJ, Konrad G, Uhl M, Südkamp N. Results after microfracture of full-thickness chondral defects in different compartments in the knee. Osteoarthritis Cartilage. 2006 Nov;14(11):1119-25.

Mithoefer K, Williams RJ 3rd, Warren RF, Potter HG, Spock CR, Jones EC, Wickiewicz TL, Marx RG. The microfracture technique for the treatment of articular cartilage lesions in the knee. A prospective cohort study. J Bone Joint Surg Am. 2005 Sep;87(9):1911-20.

Steadman JR, Briggs KK, Rodrigo JJ, Kocher MS, Gill TJ, Rodkey WG. Outcomes of microfracture for traumatic chondral defects of the knee: average 11-year follow-up. Arthroscopy. 2003 May-Jun;19(5):477-84.

Chen H, Sun J, Hoemann CD, Lascau-Coman V, Ouyang W, McKee MD, Shive MS, Buschmann MD. Drilling and microfracture lead to different bone structure and necrosis during bone-marrow stimulation for cartilage repair. J Orthop Res. 2009 Nov;27(11):1432-8.

Chen H, Hoemann CD, Sun J, Chevrier A, McKee MD, Shive MS, Hurtig M, Buschmann MD. Depth of subchondral perforation influences the outcome of bone marrow stimulation cartilage repair. J Orthop Res. 2011 Aug;29(8):1178-84.

Fortier LA, Cole BJ, McIlwraith CW. Science and animal models of marrow stimulation for cartilage repair. J Knee Surg. 2012 Mar;25(1):3-8.

Eldracher M. et al. Small Subchondral Drill Holes improve Marrow Stimulation of Articular Cartilage Defects. Am J Sports Med. 2014 Nov;42(11):2741-50.

Microfracturing is increasingly criticized as a treatment option for focal cartilage defects and, according to professional societies and cartilage experts, should only be used in exceptional cases. Nanofracturing offers an effective alternative for the treatment of chondral and osteochondral defects. NanoFx® is a bone marrow stimulation system that provides a standardized procedure for nanofracturing. Deep perforation of the subchondral plate and sub-articular cancellous bone creates direct access channels into the medullary canal through which mesenchymal stem cells (MSCs) can infiltrate into the cartilage defect. This bleeding in with accompanying recruitment of MSC is a prerequisite for cartilage regeneration. Due to the 9 mm deep perforation using NanoFx®, high yields of MSC can be achieved, promoting high-quality cartilage regeneration with a hyaline-like character. In addition, due to the 1 mm thin diameter, the subchondral plate and cancellous bone are spared, with the aim of promoting rapid healing and restoration of the subchondral bone.

ADVANTAGES OF NANOFRACTURING

• STANDARDIZED PROCEDURE
• Controlled depth of 9 mm and narrow diameter of 1 mm
• Reusable instrument with sharp disposable needles

• SUPERIOR BONE MARROW STIMULATION
• Increased stem cell yield due to deeper perforation
• Better defect filling with high collagen type 2 content

• EASY AND SAFE APPLICATION
• Smooth and fast perforation
• Facilitates restoration of subchondral bone

NANOFX^® AND HYALOFAST^®

CONVINCING ONE-STEP CARTILAGE REGENERATION WITH THE COMBINATION OF NANOFX® AND HYALOFAST®

NanoFx® and Hyalofast® offer a modern therapeutic concept for the treatment of chondral and osteochondral defects. Nanofracturing is a standardized procedure for the recruitment of mesenchymal stem cells (MSC) from the medullary canal. Matrix augmented cartilage regeneration with Hyalofast® promotes MSC differentiation to support chondrogenesis through the biological activity of hyaluronic acid. Thus, NanoFx® and Hyalofast® complement each other to form an optimal therapeutic concept for the treatment of cartilage defects.

FAST AND EASY APPLICATION

The NanoFx® Guide can be inserted into the defect arthroscopically or minimally invasively and requires no specific incisions. With the sterile disposable needle, a sharp instrument is always at hand to perforate the subchondral plate. NanoFx® is easy to put together and therefore quickly ready for use. Compared to microfracturing, the force of the hammer blow is optimally transferred to the 1 mm thin tip of the needle, so that even light blows are sufficient. Due to the integrated depth limitation, the needle is always inserted into the cancellous bone to a depth of 9 mm in a controlled manner.

Application of NanoFx®:

Step 1:

Insert the PleuriStik needle, tip down, through the opening of the Thumb Tab and through the proximal opening of the NanoFX® Guide without the needle being visible at the distal tip of the guide.

Step 2:

Place the tip of the NanoFx® Guide 2-3 mm in front of the intact cartilage wall away into the defect. Place the tip of the NanoFX® Guide only lightly on the subchondral plate.

Step 3:

Lightly tap the exposed proximal tip of the needle several times with a hammer to insert the needle into the defect to the depth limit of 9mm.

Step 4:

To retract the needle one-handed, press down on the thumb tab with your thumb. This will lever the PleuriStik needle out of the NanoFx® Guide. To perform additional perforations, reposition the guide and repeat steps 2-4.

The NanoFx® Guide is reusable and must be cleaned and sterilized after use.

NANOFX® SHORT AND COMPACT

Product: NanoFx® - Instrument for bone marrow stimulation Article: NanoFx® Guide, PleuriStik Nitinol needle, Thumb Tab Approval: medical device with CE mark Sterilization: gamma sterilized Storage: store in a dry place

DEVELOPMENT OF NANOFRACTURING

Bone marrow stimulation to recruit progenitor cells into the cartilage defect is a well-established therapeutic option in cartilage regeneration. Since the late 1980s, microfracturing emerged as the primary treatment choice because of its low cost, relatively low morbidity, and encouraging results as an initial procedure for cartilage defects, especially in young and active patients (1-3).

Renewed interest in the effects on subchondral bone shed new light on the limitations of microfracturing: shallow channels, wall compression, and an increase in trabecular wall thickness and density were observed computed tomographically and histologically (4-6). Chen et al. reported that deeper subchondral bone marrow stimulation resulted in improved cartilage defect filling, more type 2 collagen, and less type 1 collagen than shallow bone marrow access (5).

A study by Eldracher et al (7), showed that 1 mm thin holes had improved histo- gy, cancellous bone restoration, and immunoreactivity to type 2 collagen compared to 1.8 mm wide holes.

The nonstandard depth, diameter, and perforation density of microfracturing led to the development of a new method to perforate the subchondral plate (nanofracturing), which has a standardized depth of 9 mm and a diameter of 1 mm.

LITERATURE

Kreuz PC, Steinwachs MR, Erggelet C, Krause SJ, Konrad G, Uhl M, Südkamp N. Results after microfracture of full-thickness chondral defects in different compartments in the knee. Osteoarthritis Cartilage. 2006 Nov;14(11):1119-25.

Mithoefer K, Williams RJ 3rd, Warren RF, Potter HG, Spock CR, Jones EC, Wickiewicz TL, Marx RG. The microfracture technique for the treatment of articular cartilage lesions in the knee. A prospective cohort study. J Bone Joint Surg Am. 2005 Sep;87(9):1911-20.

Steadman JR, Briggs KK, Rodrigo JJ, Kocher MS, Gill TJ, Rodkey WG. Outcomes of microfracture for traumatic chondral defects of the knee: average 11-year follow-up. Arthroscopy. 2003 May-Jun;19(5):477-84.

Chen H, Sun J, Hoemann CD, Lascau-Coman V, Ouyang W, McKee MD, Shive MS, Buschmann MD. Drilling and microfracture lead to different bone structure and necrosis during bone-marrow stimulation for cartilage repair. J Orthop Res. 2009 Nov;27(11):1432-8.

Chen H, Hoemann CD, Sun J, Chevrier A, McKee MD, Shive MS, Hurtig M, Buschmann MD. Depth of subchondral perforation influences the outcome of bone marrow stimulation cartilage repair. J Orthop Res. 2011 Aug;29(8):1178-84.

Fortier LA, Cole BJ, McIlwraith CW. Science and animal models of marrow stimulation for cartilage repair. J Knee Surg. 2012 Mar;25(1):3-8.

Eldracher M. et al. Small Subchondral Drill Holes improve Marrow Stimulation of Articular Cartilage Defects. Am J Sports Med. 2014 Nov;42(11):2741-50.

Microfracturing is increasingly criticized as a treatment option for focal cartilage defects and, according to professional societies and cartilage experts, should only be used in exceptional cases. Nanofracturing offers an effective alternative for the treatment of chondral and osteochondral defects. NanoFx® is a bone marrow stimulation system that provides a standardized procedure for nanofracturing. Deep perforation of the subchondral plate and sub-articular cancellous bone creates direct access channels into the medullary canal through which mesenchymal stem cells (MSCs) can infiltrate into the cartilage defect. This bleeding in with accompanying recruitment of MSC is a prerequisite for cartilage regeneration. Due to the 9 mm deep perforation using NanoFx®, high yields of MSC can be achieved, promoting high-quality cartilage regeneration with a hyaline-like character. In addition, due to the 1 mm thin diameter, the subchondral plate and cancellous bone are spared, with the aim of promoting rapid healing and restoration of the subchondral bone.

ADVANTAGES OF NANOFRACTURING

• STANDARDIZED PROCEDURE
• Controlled depth of 9 mm and narrow diameter of 1 mm
• Reusable instrument with sharp disposable needles

• SUPERIOR BONE MARROW STIMULATION
• Increased stem cell yield due to deeper perforation
• Better defect filling with high collagen type 2 content

• EASY AND SAFE APPLICATION
• Smooth and fast perforation
• Facilitates restoration of subchondral bone

NANOFX^® AND HYALOFAST^®

CONVINCING ONE-STEP CARTILAGE REGENERATION WITH THE COMBINATION OF NANOFX® AND HYALOFAST®

NanoFx® and Hyalofast® offer a modern therapeutic concept for the treatment of chondral and osteochondral defects. Nanofracturing is a standardized procedure for the recruitment of mesenchymal stem cells (MSC) from the medullary canal. Matrix augmented cartilage regeneration with Hyalofast® promotes MSC differentiation to support chondrogenesis through the biological activity of hyaluronic acid. Thus, NanoFx® and Hyalofast® complement each other to form an optimal therapeutic concept for the treatment of cartilage defects.

FAST AND EASY APPLICATION

The NanoFx® Guide can be inserted into the defect arthroscopically or minimally invasively and requires no specific incisions. With the sterile disposable needle, a sharp instrument is always at hand to perforate the subchondral plate. NanoFx® is easy to put together and therefore quickly ready for use. Compared to microfracturing, the force of the hammer blow is optimally transferred to the 1 mm thin tip of the needle, so that even light blows are sufficient. Due to the integrated depth limitation, the needle is always inserted into the cancellous bone to a depth of 9 mm in a controlled manner.

Application of NanoFx®:

Step 1:

Insert the PleuriStik needle, tip down, through the opening of the Thumb Tab and through the proximal opening of the NanoFX® Guide without the needle being visible at the distal tip of the guide.

Step 2:

Place the tip of the NanoFx® Guide 2-3 mm in front of the intact cartilage wall away into the defect. Place the tip of the NanoFX® Guide only lightly on the subchondral plate.

Step 3:

Lightly tap the exposed proximal tip of the needle several times with a hammer to insert the needle into the defect to the depth limit of 9mm.

Step 4:

To retract the needle one-handed, press down on the thumb tab with your thumb. This will lever the PleuriStik needle out of the NanoFx® Guide. To perform additional perforations, reposition the guide and repeat steps 2-4.

The NanoFx® Guide is reusable and must be cleaned and sterilized after use.

NANOFX® SHORT AND COMPACT

Product: NanoFx® - Instrument for bone marrow stimulation Article: NanoFx® Guide, PleuriStik Nitinol needle, Thumb Tab Approval: medical device with CE mark Sterilization: gamma sterilized Storage: store in a dry place

DEVELOPMENT OF NANOFRACTURING

Bone marrow stimulation to recruit progenitor cells into the cartilage defect is a well-established therapeutic option in cartilage regeneration. Since the late 1980s, microfracturing emerged as the primary treatment choice because of its low cost, relatively low morbidity, and encouraging results as an initial procedure for cartilage defects, especially in young and active patients (1-3).

Renewed interest in the effects on subchondral bone shed new light on the limitations of microfracturing: shallow channels, wall compression, and an increase in trabecular wall thickness and density were observed computed tomographically and histologically (4-6). Chen et al. reported that deeper subchondral bone marrow stimulation resulted in improved cartilage defect filling, more type 2 collagen, and less type 1 collagen than shallow bone marrow access (5).

A study by Eldracher et al (7), showed that 1 mm thin holes had improved histo- gy, cancellous bone restoration, and immunoreactivity to type 2 collagen compared to 1.8 mm wide holes.

The nonstandard depth, diameter, and perforation density of microfracturing led to the development of a new method to perforate the subchondral plate (nanofracturing), which has a standardized depth of 9 mm and a diameter of 1 mm.

LITERATURE

Kreuz PC, Steinwachs MR, Erggelet C, Krause SJ, Konrad G, Uhl M, Südkamp N. Results after microfracture of full-thickness chondral defects in different compartments in the knee. Osteoarthritis Cartilage. 2006 Nov;14(11):1119-25.

Mithoefer K, Williams RJ 3rd, Warren RF, Potter HG, Spock CR, Jones EC, Wickiewicz TL, Marx RG. The microfracture technique for the treatment of articular cartilage lesions in the knee. A prospective cohort study. J Bone Joint Surg Am. 2005 Sep;87(9):1911-20.

Steadman JR, Briggs KK, Rodrigo JJ, Kocher MS, Gill TJ, Rodkey WG. Outcomes of microfracture for traumatic chondral defects of the knee: average 11-year follow-up. Arthroscopy. 2003 May-Jun;19(5):477-84.

Chen H, Sun J, Hoemann CD, Lascau-Coman V, Ouyang W, McKee MD, Shive MS, Buschmann MD. Drilling and microfracture lead to different bone structure and necrosis during bone-marrow stimulation for cartilage repair. J Orthop Res. 2009 Nov;27(11):1432-8.

Chen H, Hoemann CD, Sun J, Chevrier A, McKee MD, Shive MS, Hurtig M, Buschmann MD. Depth of subchondral perforation influences the outcome of bone marrow stimulation cartilage repair. J Orthop Res. 2011 Aug;29(8):1178-84.

Fortier LA, Cole BJ, McIlwraith CW. Science and animal models of marrow stimulation for cartilage repair. J Knee Surg. 2012 Mar;25(1):3-8.

Eldracher M. et al. Small Subchondral Drill Holes improve Marrow Stimulation of Articular Cartilage Defects. Am J Sports Med. 2014 Nov;42(11):2741-50.

Microfracturing is increasingly criticized as a treatment option for focal cartilage defects and, according to professional societies and cartilage experts, should only be used in exceptional cases. Nanofracturing offers an effective alternative for the treatment of chondral and osteochondral defects. NanoFx® is a bone marrow stimulation system that provides a standardized procedure for nanofracturing. Deep perforation of the subchondral plate and sub-articular cancellous bone creates direct access channels into the medullary canal through which mesenchymal stem cells (MSCs) can infiltrate into the cartilage defect. This bleeding in with accompanying recruitment of MSC is a prerequisite for cartilage regeneration. Due to the 9 mm deep perforation using NanoFx®, high yields of MSC can be achieved, promoting high-quality cartilage regeneration with a hyaline-like character. In addition, due to the 1 mm thin diameter, the subchondral plate and cancellous bone are spared, with the aim of promoting rapid healing and restoration of the subchondral bone.

ADVANTAGES OF NANOFRACTURING

• STANDARDIZED PROCEDURE
• Controlled depth of 9 mm and narrow diameter of 1 mm
• Reusable instrument with sharp disposable needles

• SUPERIOR BONE MARROW STIMULATION
• Increased stem cell yield due to deeper perforation
• Better defect filling with high collagen type 2 content

• EASY AND SAFE APPLICATION
• Smooth and fast perforation
• Facilitates restoration of subchondral bone

NANOFX^® AND HYALOFAST^®

CONVINCING ONE-STEP CARTILAGE REGENERATION WITH THE COMBINATION OF NANOFX® AND HYALOFAST®

NanoFx® and Hyalofast® offer a modern therapeutic concept for the treatment of chondral and osteochondral defects. Nanofracturing is a standardized procedure for the recruitment of mesenchymal stem cells (MSC) from the medullary canal. Matrix augmented cartilage regeneration with Hyalofast® promotes MSC differentiation to support chondrogenesis through the biological activity of hyaluronic acid. Thus, NanoFx® and Hyalofast® complement each other to form an optimal therapeutic concept for the treatment of cartilage defects.

FAST AND EASY APPLICATION

The NanoFx® Guide can be inserted into the defect arthroscopically or minimally invasively and requires no specific incisions. With the sterile disposable needle, a sharp instrument is always at hand to perforate the subchondral plate. NanoFx® is easy to put together and therefore quickly ready for use. Compared to microfracturing, the force of the hammer blow is optimally transferred to the 1 mm thin tip of the needle, so that even light blows are sufficient. Due to the integrated depth limitation, the needle is always inserted into the cancellous bone to a depth of 9 mm in a controlled manner.

Application of NanoFx®:

Step 1:

Insert the PleuriStik needle, tip down, through the opening of the Thumb Tab and through the proximal opening of the NanoFX® Guide without the needle being visible at the distal tip of the guide.

Step 2:

Place the tip of the NanoFx® Guide 2-3 mm in front of the intact cartilage wall away into the defect. Place the tip of the NanoFX® Guide only lightly on the subchondral plate.

Step 3:

Lightly tap the exposed proximal tip of the needle several times with a hammer to insert the needle into the defect to the depth limit of 9mm.

Step 4:

To retract the needle one-handed, press down on the thumb tab with your thumb. This will lever the PleuriStik needle out of the NanoFx® Guide. To perform additional perforations, reposition the guide and repeat steps 2-4.

The NanoFx® Guide is reusable and must be cleaned and sterilized after use.

NANOFX® SHORT AND COMPACT

Product: NanoFx® - Instrument for bone marrow stimulation Article: NanoFx® Guide, PleuriStik Nitinol needle, Thumb Tab Approval: medical device with CE mark Sterilization: gamma sterilized Storage: store in a dry place

DEVELOPMENT OF NANOFRACTURING

Bone marrow stimulation to recruit progenitor cells into the cartilage defect is a well-established therapeutic option in cartilage regeneration. Since the late 1980s, microfracturing emerged as the primary treatment choice because of its low cost, relatively low morbidity, and encouraging results as an initial procedure for cartilage defects, especially in young and active patients (1-3).

Renewed interest in the effects on subchondral bone shed new light on the limitations of microfracturing: shallow channels, wall compression, and an increase in trabecular wall thickness and density were observed computed tomographically and histologically (4-6). Chen et al. reported that deeper subchondral bone marrow stimulation resulted in improved cartilage defect filling, more type 2 collagen, and less type 1 collagen than shallow bone marrow access (5).

A study by Eldracher et al (7), showed that 1 mm thin holes had improved histo- gy, cancellous bone restoration, and immunoreactivity to type 2 collagen compared to 1.8 mm wide holes.

The nonstandard depth, diameter, and perforation density of microfracturing led to the development of a new method to perforate the subchondral plate (nanofracturing), which has a standardized depth of 9 mm and a diameter of 1 mm.

LITERATURE

Kreuz PC, Steinwachs MR, Erggelet C, Krause SJ, Konrad G, Uhl M, Südkamp N. Results after microfracture of full-thickness chondral defects in different compartments in the knee. Osteoarthritis Cartilage. 2006 Nov;14(11):1119-25.

Mithoefer K, Williams RJ 3rd, Warren RF, Potter HG, Spock CR, Jones EC, Wickiewicz TL, Marx RG. The microfracture technique for the treatment of articular cartilage lesions in the knee. A prospective cohort study. J Bone Joint Surg Am. 2005 Sep;87(9):1911-20.

Steadman JR, Briggs KK, Rodrigo JJ, Kocher MS, Gill TJ, Rodkey WG. Outcomes of microfracture for traumatic chondral defects of the knee: average 11-year follow-up. Arthroscopy. 2003 May-Jun;19(5):477-84.

Chen H, Sun J, Hoemann CD, Lascau-Coman V, Ouyang W, McKee MD, Shive MS, Buschmann MD. Drilling and microfracture lead to different bone structure and necrosis during bone-marrow stimulation for cartilage repair. J Orthop Res. 2009 Nov;27(11):1432-8.

Chen H, Hoemann CD, Sun J, Chevrier A, McKee MD, Shive MS, Hurtig M, Buschmann MD. Depth of subchondral perforation influences the outcome of bone marrow stimulation cartilage repair. J Orthop Res. 2011 Aug;29(8):1178-84.

Fortier LA, Cole BJ, McIlwraith CW. Science and animal models of marrow stimulation for cartilage repair. J Knee Surg. 2012 Mar;25(1):3-8.

Eldracher M. et al. Small Subchondral Drill Holes improve Marrow Stimulation of Articular Cartilage Defects. Am J Sports Med. 2014 Nov;42(11):2741-50.

The PCL Spit Rapid Spit Test is an in vitro diagnostic medical device based on a rapid immunochromatographic assay (ICA) procedure and is designed for the qualitative detection of SARS-CoV-2 antigens in human saliva specimens.

Available in the following packaging units:

1 pc. Pack, 5 pcs. Pack and 50 pcs. Pack

Specimen Collection

1. The person being tested collects saliva near the tip of the tongue (approximately 0.5 mL) for 30 seconds with the mouth closed.

2. Spit the collected saliva directly into the tube with extraction buffer for immediate use. The funnel attachment can be used to assist in this process. The addition of saliva should approximately double the volume contained in the tube.

3. Close the tube tightly with the filter cap. Mix the contents by turning it upside down 10 times. (Open test card pouch immediately before use. Failure to use the pouch immediately after opening may affect the accuracy of the results).

4. Open test card pouch and place test card on a flat surface. Add a few drops of the mixture of saliva sample and extraction buffer to the application position of the Test Card. The application opening should be almost completely filled. Always use at least 2-3 drops.

5. Read the result after 10 minutes

Very high hyaluronic acid active ingredient content in only one injection

KEYFACTS

Very high active ingredient content

• For proven fast and long-lasting pain relief

Patented crosslinking process

• Ensures long-lasting retention of hyaluronic acid in the joint

Outstanding efficacy and safety record

• FDA approval through placebo-controlled, randomized, double-blind, multicenter study

Maximum safety

• Only one injection per therapy cycle and 10 years of Monovisc therapy experience

Active ingredient content

VERY HIGH ACTIVE INGREDIENT CONTENT AND CROSS-LINKING FOR LESS PAIN

• MONOVISC® delivers a high active ingredient content compared to other cross-linked one-shot preparations on the market. One 4 ml injection contains 88 mg of hyaluronic acid at a concentration of 22 mg/ml.

• Injecting high-dose MONOVISC® reduces pain better than other preparations and prolongs the pain-free phase.

• MONOVISC® is produced in a patented crossliniking process and has a slightly crosslinked molecular structure. The resulting stabilized hyaluronic acid remains in the joint longer.

MONOVISC® - SHORT AND COMPACT

• Hyaluronic acid active ingredient content: 88 mg
• Therapy: 1 injection
• Content: 1 prefilled syringe (4 ml)
• Fields of application: Approved for all synovial joints
• Approval: FDA approval*, medical device with CE mark

The first combination preparation of hyaluronic acid and cortisone

KEYFACTS

2 IN 1 - COMBINATION PREPARATION

• Unique combination of hyaluronic acid with patented crosslinking technology and the cortisone triamcinolone hexacetonide

1+ QUALITY

• Crosslinked hyaluronic acid with high active ingredient content (88 mg)
• Biotechnological manufacturing process of fermentation, free of animal proteins

A PLUS FOR PATIENTS

• Only 1 injection in the therapy cycle
• Fast and long-lasting pain relief and improved joint mobility
• Ideal for (competitive) athletes and professionals who expect a fast effect and have little time for repeated injections

Efficacy

FAST AND LONG-LASTING EFFICACY

• CINGAL® is the first "ready to use" combination product for dual efficacy. Injected into the diseased region, the crystal suspension breaks down slowly but provides immediate pain relief.

• CINGAL® provides faster pain relief than hyaluronic acid without cortisone

• CINGAL® acts even faster than cross-linked hyaluronic acid alone. Significant pain reduction is seen at weeks 1 and 3.

• Patients in the CINGAL® study confirm long-lasting pain relief

• The course of pain reduction suggests an even longer efficacy of CINGAL® (significantly more than 26 weeks)

CINGAL® - SHORT AND COMPACT

• Hyaluronic acid active ingredient content: 88 mg
• Triamcinolone hexacetonide active ingredient content: 18 mg
• Therapy: 1 injection
• Content: 1 prefilled syringe (4 ml)
• Indications: Approved for all synovial joints
• Approval: Medical device with CE mark

Especially for small joints - synovial joints.

Orthovisc® mini is a highly pure hyaluronic acid preparation that improves joint function in osteoarthritis, contributes to long-lasting pain relief, and halts the progressive degeneration process in cartilage.

KEYFACTS

EFFECTIVE

• Optimal molecular weight
• Excellent viscoelastic properties
• Long lasting pain relief and improved mobility

SAFE

• Optimal tolerability due to high degree of purity
• Proof of safety and efficacy through FDA approval
• Over 20 years of ORTHOVISC® therapy experience
• Biotechnological manufacturing process of fermentation; free of animal proteins

PATIENT-FRIENDLY

• Only 3 injections per therapy cycle
• Reduced risk of infection
• No pseudoseptic reactions in over 6 million injections worldwide

PROVEN EFFICACY WITH FDA APPROVAL

ORTHOVISC® mini is a highly pure hyaluronic acid preparation that improves joint function in osteoarthritis, contributes to long-lasting pain relief and halts the progressive degeneration process in cartilage.

Optimal molecular weight

• Orthovisc has a molecular weight of 1.80 x 106 while maintaining high rheological viscosity.
• Granulomatous inflammation, which seems to be induced by very high molecular weight preparations due to their low solubility, can be virtually eliminated.

Optimum viscosity

• Orthovisc retains its viscosity optimally under load. Preparations quickly lose their viscoelastic properties under load and liquefy.
• Orthovisc excellently improves the viscoelasticity of the synovial fluid. Lubricating and shock-absorbing properties are produced.

ORTHOVISC® mini – SHORT AND COMPACT

• Hyaluronic acid active ingredient content: 15 mg/injection
• Therapy: 3 injections (recommended)
• Content: 1 prefilled syringe (1 ml)
• Fields of application: Optimal for synovial joints
• Approval: FDA approval*, medical device with CE mark

Orthovisc® is a highly pure hyaluronic acid preparation that improves joint function in osteoarthritis, contributes to long-lasting pain relief, and halts the progressive degeneration process in cartilage.

KEYFACTS

EFFECTIVE

• Optimal molecular weight
• Excellent viscoelastic properties
• Long lasting pain relief and improved mobility

SAFE

• Optimal tolerability due to high degree of purity
• Proof of safety and efficacy through FDA approval
• Over 20 years of ORTHOVISC® therapy experience
• Biotechnological manufacturing process of fermentation; free of animal proteins

PATIENT-FRIENDLY

• Only 3 injections per therapy cycle
• Reduced risk of infection
• No pseudoseptic reactions in over 6 million injections worldwide

ORTHOVISC mini

• Especially for small joints

PROVEN EFFICACY WITH FDA APPROVAL

ORTHOVISC® is a highly pure hyaluronic acid preparation that improves joint function in osteoarthritis, contributes to long-lasting pain relief and halts the progressive degeneration process in cartilage.

Optimal molecular weight

• Orthovisc has a molecular weight of 1.80 x 106 while maintaining high rheological viscosity.
• Granulomatous inflammation, which seems to be induced by very high molecular weight preparations due to their low solubility, can be virtually eliminated.

Optimum viscosity

• Orthovisc retains its viscosity optimally under load. Preparations quickly lose their viscoelastic properties under load and liquefy.
• Orthovisc excellently improves the viscoelasticity of the synovial fluid. Lubricating and shock-absorbing properties are established.

ORTHOVISC® - SHORT AND COMPACT

• Hyaluronic acid active ingredient content: 30 mg/injection
• Therapy: 3 injections (recommended)
• Content: 1 ready-to-use syringe (2 ml)
• Fields of application: Optimal for small joints
• Approval: FDA approval*, medical device with CE mark

ORTHOVISC®-T is an injectable viscoelastic sodium hyaluronate solution for the treatment of chronic lateral epicondylopathy. 

ORTHOVISC®-T acts as a lubricant to help the tendon glide in the tendon sheath. This supports the healing process of the tendon.

KEYFACTS

PROVEN EFFICACY

• Optimal molecular weight
• Excellent viscoelastic properties
• Proven improvement of tendon biomechanics
• Promotion of tendon healing
• Sustained pain relief and improved mobility

PROVEN SAFETY

• Optimal tolerability due to high degree of purity
• Biotechnological process of biofermentation; free of animal proteins
• Over 20 years of ORTHOVISC® therapy experience
• Only 2 injections in the therapy cycle

THE THERAPY OPTION FOR THE TREATMENT OF PAIN AND LIMITED MOBILITY ASSOCIATED WITH TENDON DISORDERS

Orthovisc-T improves tendon biomechanics

• In a clinical study, patients treated with hyaluronic acid injections for lateral epicondylopathy showed significant improvement in VAS pain score - compared to those who received coricosteroid injections.
• The result lasted up to one year after injection.

ORTHOVISC®-T - SHORT AND COMPACT

• Hyaluronic acid active ingredient content: 30 mg/injection
• Therapy: 2 injections
• Content: 1 prefilled syringe (2 ml)
• Fields of application: Approved for the treatment of tendon disorders due to chronic lateral epicondylopathy.
• Approval: Medical device with CE mark

Autologous Conditioned Serum for the preparation of an autologous conditioned serum.

Application

• Osteoarthritis, especially activated osteoarthritis, e.g. in knee joints
• Degenerative spinal diseases (e.g. spondyarthrosis, osteochondrosis, spondylosis, degenerative spinal stenosis)
• Nerve compression syndrome (e.g. disc protrusion, disc prolapse, degenerative neuroforaminal stenosis)
• Back pain

Focus and goal of therapy

• The particular focus of ACS therapy is on anti-inflammation and pain relief.

• Osteoarthritis: Inflammatory processes with significant role in pathogenesis
• Cytokine imbalance: IMPACT ACS provides balance
• Goal of ACS therapy: Increase the body's own protective proteins

Without anticoagulant for the preparation of lightly concentrated platelet-rich plasma.

Application

wPRP - Acute:

• Tendon injuries, including Achilles tendon, rotator cuff
• Ligament injuries, e.g. cruciate ligament, ankle ligaments
• Muscle fiber tear
• Meniscus injury

wPRP – Chronic

• Tendinopathy, e.g., Achilles tendon thickening/ Chronic Achilles tendon rupture (Achillodynia)
• Tendon irritation, e.g. patellar tendon syndrome
• Subacromial syndrome
• Tendonitis

Concentration / Yield

Autologous Platelet Concentrate with anticoagulant for the preparation of highly concentrated platelet concentrate.

Application

• Ligament tears (lateral and external ligament)
• Bursitis (bursitis trochanterica)
• Plantar fasciitis
• Lateral epicondylitis/tennis elbow
• Pseudarthrosis
• Avascular necrosis, e.g. knee, hip
• ACL reconstruction

Concentration / Yield

• Natural healing cascade
• Growth factors in platelet concentrate significantly increased

The IMPACT system offers the user the possibility to produce different autologous blood products with only one platform. Autologous blood products use the body´s own regeneration mechanisms. After injection to the defect, they support the body in healing injured tissue in a purely natural way. IMPACT´s innovative technology allows variable concentrations of leukocytes and platelets.

Content: Impact centrifuge, rolling container, Neolab rotator 90-27 degrees adjustable, Neolab turntable f. rotator

KEYFACTS

ÜBERLEGENES HANDLING

• Fully automated system
• Therapy preparation: fast and easy
• Therapy is immediately ready for use (ready-to-use)

UNIQUE RESULTS

• High platelet yield
• High yield of growth factors and anti-inflammatory cytokines
• Presence/absence of leukocytes is user-defined

HIGH FLEXIBILITY

• One system for variety of different autologous cell therapies
• Scientifically proven IMPACT programs
• Use for practice and surgery

MAXIMUM SAFETY

• Closed system
• High reproducibility of excellent results

Reliable technology for reproducible results

With IMPACT, centrifugation and separation of the desired blood fractions takes place fully automatically in a closed system. The built-in optical sensor is adjustable in its sensitivity and separates reliably and accurately. The syring containing the patient´s blood is inserted and - after the program has run down - the desired autologous blood product is withdran "ready to use".

Innovative and customizable production of autologous blood products - with just one system

Three treatment sets are available. The selection is made depending on the respective therapy goal:

IMPACT PRP – Platelet Rich Plasma

IMPACT APC – Autologous Platelet Concentrate

IMPACT ACS – Autologous Conditioned Serum