Technical Sheet Chondrotissue Page 1 of 4

Technical Sheet chondrotissue®Page 1 of 4

Name of medical device

chondrotissue®

Use of the medical device

Used for intra-articular haemostasis and for protecting underlying tissue when there is pain and restricted freedom of movement in cases of degenerative and traumatic changes in the synovial joints.

Indications

Used in the Pridie drilling and microfracture procedure for haemostasis and for protecting underlying tissue in cases of degenerative and traumatic changes in the articular cartilage. It contains hyaluronic acid, a natural polymer which carries out important functions in articulation, helping to keep the cartilage elastic, and protecting it against friction, stress and shock.

Classification of the medical device

Class III medical device (Medical Devices Directive 93/42/EEC)

Contraindications and precautions

Do not use if there is any known hypersensitivity to one of the product ingredients. Do not implant directly into the bloodstream and do not use in patients who are due to undergo chemotherapy and/or radiotherapy up to three weeks after implantation. As there is insufficient experimental data on the use of hyaluronic acid in children and pregnant or lactating women or patients with inflammatory joint diseases, such as rheumatoid arthritis and Bechterew’s disease, use of the product is not recommended in these patients. In cases of infections or suspected infections at the implantation site, the surgeon must consider the potential risk-benefit ratio. Do not use if the aluminium bag or container are damaged.

Warnings

It is a disposable product and cannot be resterilised. The user is solely responsible for adverse consequences if the instructions for use are not followed. General rules for asepsis must be strictly observed when using the product. It should not be used as a temporary tissue replacement, as it is exposed to excessive mechanical stress. The surgeon carrying out the implantation is required to respect the same principles applicable as when using absorbable PGA suture material, in particular the loss of mechanical resistance after implant. The reabsorption process may be delayed in the case of bradytrophic tissue. In such cases, the product or its hydrolysis products may cause local irritations, being foreign bodies.

Side effects

Acute and chronic foreign body reactions, infections, as well as local concomitant symptoms in the treated joint, such as pain, sensation of heat, redness and swelling, may also occur after implantation.

Interactions with other agents

Do not place product in contact with instruments that have been sterilised with solutions of quaternary ammonium salts. So far, no incompatibility with other solutions and substances applied to intra-articular sites has been made public. Concomitant administration of oral analgesic and anti-inflammatory drugs during the early phase of treatment may be useful for the patient.

Components of the medical device

Polyglycolic acid and sodium hyaluronate

Sizes available

1 unit of 20 x 30 x 1.1 mm

Materials and manufacturing techniques

Polyglycolic acid fleece and freeze-dried sodium hyaluronate.

It is manufactured with great care and strict quality controls by BioTissue.

Production takes place under sterile conditions in a GMP laboratory. The fleece with hyaluronic acid is freeze-dried and then packaged in a sterile bag.

Before being put on sale, the product undergoes numerous procedures to ensure its sterility. Every batch undergoes specific laboratory tests: sterility check on 20 units, viscosity check on 10 units. Another 5 items are stored for potential traceability analysis. A total of 35 units from each batch undergo checks to ensure maximum product safety.

Both materials and manufacturing techniques are compliant with community directive 93/42/EEC.

In terms of safety, the product meets the requirements of current European directives, as well as the strict German national laws [Medizinproduktegesetz: German law on medical devices].

Features of the medical device

Available in freeze-dried form, white and rigid. PGA fleece is biocompatible and is reabsorbed completely in just a few weeks. It carries out a haemostatic function in the case of diffuse tissue haemorrhaging, such as after the Pridie drilling or microfracture procedure.

Sterilisation

Produced in sterile GMP conditions using components which are already sterile, i.e. radiation-sterilised PGA fleece, steam-sterilised hyaluronic acid, radiation-sterilised packaging.

Packaging specifications

Packaged in polystyrene Petri dishes with an outer aluminium container and a protective cardboard box.

Instructions for storage

Store in a dry place at room temperature. Protect from direct sunlight and great temperature variations, which may occur, for example, close to radiators and air conditioners. Do not store near sources of radiation. Check expiry date. Keep out of the reach of children.

Use

To use the product, open the aluminium container. Remove and open the sterile bag. In order to restore the elastic properties of the product, it is recommended to soak the fleece with autologous serum before implantation. This step can take place inside the sterile bag itself. Prepare the joint defect so as to be able to apply the moistened fleece. It can be cut to fit the exact size of the defect and stuck with fibrin glue, bioresorbable nails (e.g. SmartNail®, ConMed Linvatec Biomaterials Ltd), suture thread or transosseous fixation (Erggelet’s technique).

Instrumentation

chondrotissue® can be purchased on its own, without instrumentation. It is, however, recommended that Linvatec Conmed arthroscopy instruments be purchased for arthroscopic fixation with resorbable nails (SmartNail®, ConMed Linvatec Biomaterials Ltd).

Year of release

2007

CE marking

0535

Name and address of the manufacturer

BioTissue AG

Scheideggstrasse 73

CH-8038 Zürich

Name and address of the distributor

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Labelling

Version: 001-2009 ts-enStatus: 01.04.09