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Collagen Matrix, Inc. Receives FDA 510(k) Clearance for Collagen Nerve Wrap |
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07 Aug 2006 |
Announced today that it has received FDA's 510(k) clearance of its Collagen Nerve Wrap indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue and where gap closure can be achieved by flexion of the extremity.
FRANKLIN LAKES, NJ, USA | Aug 07, 2006 | Collagen Matrix, Inc. announced today that it has received FDA's 510(k) clearance of its Collagen Nerve Wrap indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue and where gap closure can be achieved by flexion of the extremity.
Collagen Nerve Wrap is a resorbable collagen matrix that provides a non-constricting encasement for injured peripheral nerves for protection of the neural environment. Collagen Nerve Wrap is designed to be an interface between the nerve and the surrounding tissue. When hydrated, Collagen Nerve Wrap is an easy to handle, soft, pliable, nonfriable, porous collagen matrix. The proprietary design of the product allows Collagen Nerve Wrap to be spread open for easy placement over the injured nerve and to maintain closure without sutures. Collagen Nerve Wrap is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, in double peel packages.
"As we continue our advanced research and development in the area of peripheral nerve repair under the NIH-funded bioactive nerve guide project for long gap nerve injuries, the Collagen Nerve Wrap product line addresses an immediate clinical need in the area of crush injuries or short gap nerve injuries. This regulatory clearance further demonstrates our commitment to the area of peripheral nerve repair," said Shu-Tung Li, Ph.D., Founder and CEO of Collagen Matrix.
Collagen Matrix, Inc. is a leader in the design and engineering of collagen-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 orthopedic tissue regeneration applications. The Company currently manufactures collagen-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: Shu-Tung Li, Ph.D. 201-405-1477
SOURCE: Collagen Matrix, Inc |
