CardioCel®

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Product Name CardioCel®
Incorporated Materials Bovine Pericardial Tissue consisting of Collagen and Elastin (less than 1%)
Size 4x4cm
Thickness 0.3-0.8mm
Morphology Smooth surface and rough surface (opposite side). No visual evidence of scratches or tears
Crosslinking Stability 80°C ± 5°C
Sterility Provided sterile.
Endotoxin LAL: < 0.5 EU/ml (20 EU per device). Meets the biocompatibility requirements of ISO 10993
Storage Stored in solution of propylene oxide (clear solution with no debris or cloudiness)
Storage temperatures Between 2°C and 25°C
Shelf-life 2 years
User safety requirements: Restricted to sale by or on the order of a physician

CardioCel®

CardioCel® is a single-ply, bio-scaffold that remains functional, durable and free from calcification.

It can be used to repair congenital heart deformities and more complex heart defects.
The adapted collagen scaffold also has the potential to be used in the repair and reconstruction of dysfunctional heart valves and valve leaflets, with longer term possibilities for use in the manufacture of replacement tissue heart valves.

CardioCel

CardioCel® overcomes problems associated with current materials on the market by providing surgeons with a tissue bio-implant that is not only durable, but its’ natural flexibility and elasticity makes it easier to handle and use and so allows surgeons to more easily work on complex cardiac repairs and their continuum of care.
Doctors around the world are using CardioCel with thousands of patients at hundreds of centres across the world having been implanted with CardioCel®.

CardioCel® is on the market in the US, Canada, Singapore and Europe and is available to surgeons via Special Access Schemes in Australia and other parts of Asia.

CardioCel® also has the potential to treat a range of other conditions which benefit from the use of a tissue scaffold.

Clinical studies have shown no calcification after seven years, with strong ingrowth of normal heart tissue around the scaffold and strong blood-flow through and around the implant.

Heart Valve Reconstruction & Repair

CardioCel® has been approved for heart valve and vessel repair and reconstruction in the US.

How CardioCel® Works

More Information

For more information please download our brochure.