Technology | May 26, 2008

FDA Clears TenoMend Collagen Tendon Wrap for the Management of Tendon Injuries

Collagen Matrix Inc. received FDA 510(k) clearance in May 2008 for its TenoMend Collagen Tendon Wrap indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

TenoMend Collagen Tendon Wrap is a resorbable type one collagen matrix that provides a non-constricting encasement for injured tendons. It is designed to be an interface between the tendon and tendon sheath or the surrounding tissue. When hydrated, the wrap is said to be a conformable, nonfriable, self-curling collagen sheet designed for easy placement under, around or over the injured tendon. The patented self-curling wrap design offers the ability to implant with minimal suturing. The device provides a protected environment and gliding surface of the sheath for tendon healing.

In trauma cases, fractures and injuries of bones in the extremities typically result in injury of the associated soft tissue such as tendon and peripheral nerves. Tendon scarring can often occur as a result of tendon repair. When tendon scarring occurs, other structures such as joints may lose normal range of motion.

The results of an animal flexor tendon repair study using the TenoMend Collagen Tendon Wrap demonstrated the ease of implantation with the tendon’s return to full range of motion comparable to normal unsevered tendons. The controls in which severed tendons were repaired but not wrapped, demonstrated statistically significant reduction in range of motion.

May 2008

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