Collagen Matrix, Inc. Receives FDA 510(k) Clearance for TenoMend(TM) Collagen Tendon Wrap for the Management and Protection of Tendon Injuries
Published: May 27, 2008
FRANKLIN LAKES, N.J., May 27 /PRNewswire/ -- Collagen Matrix, Inc. announced today that it has received the United States Food and Drug Administration's 510(k) clearance of its TenoMend(TM) Collagen Tendon Wrap indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
TenoMend(TM) Collagen Tendon Wrap is a resorbable type 1 collagen matrix that provides a non-constricting encasement for injured tendons. TenoMend(TM) Collagen Tendon Wrap is designed to be an interface between the tendon and tendon sheath or the surrounding tissue. When hydrated, TenoMend(TM) Collagen Tendon Wrap is 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.
Collagen Matrix's portfolio of orthopaedic products now includes solutions for bone, tendon, and peripheral nerve repair. With Collagen Matrix's OssiGuide(TM) Cancellous Granules, OssiMend(TM) and OssiMend(TM) Putty Mineral-Collagen Composites, OssiPatch(TM) Bone Healing Protective Sheet, NeuroMatrix(TM) Collagen Nerve Conduit, Neuroflex(TM) Flexible Collagen Nerve Conduit, NeuroMend(TM) Collagen Nerve Wrap and TenoMend(TM) Collagen Tendon Wrap, the surgeon is equipped with the products needed to repair a complex injury.
The results of an animal flexor tendon repair study using TenoMend(TM) 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. TenoMend(TM) Collagen Tendon Wrap was successful in providing a protective environment for tendon repair.
"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(TM) Collagen Tendon Wrap is the first in a series of tendon repair products under development," said Shu-Tung Li, Ph.D., Founder and CEO of Collagen Matrix. "We are currently exploring potential product marketing and distribution opportunities for worldwide distribution of TenoMend(TM) Collagen Tendon Wrap, which is available immediately," he added.
Collagen Matrix, Inc. is a leader in the design and engineering of collagen- and mineral-based extracellular matrices for tissue and organ repair and regeneration. Since its inception in 1997, the Company has received many government grants for the development of collagen-based matrix products in the areas of neurological, vascular, urological, and orthopaedic tissue regeneration applications. The Company currently manufactures collagen- and mineral-based finished medical devices in the areas of neurosurgery, oral surgery, orthopedic-spine surgery, and wound care. More information about the Company can be found at www.collagenmatrix.com.
CONTACT: Peggy Hansen, RAC, Sr. Director, Clinical, Regulatory, and
Quality Assurance of Collagen Matrix, Inc., +1-201-405-1477, fax
Web site: http://www.collagenmatrix.com/