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news.Collagen Matrix has received the FDA's 510(k) clearance of 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.
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TenoMend collagen tendon wrap is a resorbable type 1 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. The device provides a protected environment and gliding surface of the sheath for tendon healing.
The results of an animal flexor tendon repair study using 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.
Shu-Tung Li, founder and CEO of Collagen Matrix, said: “We are committed to providing the surgical community with a full line of products to address complicated orthopaedic injuries involving hard and soft tissues. TenoMend collagen tendon wrap is the first in a series of tendon repair products under development.”