News | February 21, 2007

Protector Sheet FDA Cleared for Management of Tendon Injuries

Feb. 22, 2007 - Integra LifeSciences Holdings Corp. has received FDA clearance to market TenoGlide Tendon Protector Sheet in the US. The product is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. It is an advanced tendon protection device, composed of a porous matrix of cross-linked collagen and glycosaminoglycan (GAG). The collagen-GAG resorbable matrix provides a protective, biocompatible interface, which creates a favorable environment and gliding surface for tendon healing. Based on available
procedural data, Integra estimates that the worldwide market for the protection of tendon injuries is over $100 million.

"In our pre-clinical studies, the data indicate that the use of TenoGlide Tendon Protector Sheet during tendon repair in an animal model significantly reduced formation of scar tissue between the tendon and surrounding tissue, as compared to untreated controls," said Mayer Tenenhaus M.D., FACS, Associate Clinical Professor of Surgery/Plastic Surgery at University of California, San Diego.

Since tendon and peripheral nerve injuries often occur together, TenoGlide Tendon Protector Sheet can be used in conjunction with two previously cleared Integra products: NeuraGen Nerve Guide for completely transected nerves, and NeuraWrap Nerve Protector for nerve injuries, which include compressed or scarred nerves.

TenoGlide Tendon Protector Sheet will be sold by Integra's Extremity Reconstruction sales organization, which includes over 60 U.S. sales specialists focused on lower extremity fixation, upper extremity fixation, wound repair, tendon protection, and peripheral nerve repair/protection.

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