Collagen Matrix, Inc. announced today that it has received FDA’s 510(k) clearance of its Flexible Collagen Nerve Conduit for management of peripheral nerve injuries at nerve ends in the foot to reduce the formation of painful neuroma. This is the first and only nerve conduit to receive FDA clearance for treatment of neuroma formation at nerve ends. The product will be able to help patients suffering from pain as a result of conditions such as Morton’s neuroma affecting the ball of the foot, amputations or other nerve damage in the foot.
Flexible Collagen Nerve Conduit is a resorbable, flexible type I collagen tubular matrix that provides both an encasement for peripheral nerve injuries as well as protection of the neural environment. It is designed to be an interface between the nerve and the surrounding tissue (e.g., to prevent ingrowth of scar tissue). When placed at the terminal end of a nerve, the conduit is designed to prevent formation of neuroma. When hydrated, the product is a flexible collagen conduit where the crimped walls provide a kink-resistant property to the tube. This kink-resistant property of the conduit is of particular importance when applied to the nerve end, because it allows the natural outgrowth of the regenerating axons of the injured proximal nerve stump to be guided without hindrance (e.g. blockage/kinking of the conduit) to the point where the nerve will no longer be capable of forming a neuroma.
The clinical benefit of the use of the Flexible Collagen Nerve Conduit in reducing the formation of painful neuromas has been demonstrated by Dr. John S. Gould of the University of Alabama at Birmingham. In his study, a total of fifty patients successfully underwent treatment of painful single or multiple neuromas by excision and implantation of the resected nerve end into the Flexible Collagen Nerve Conduit.
“As we continue our advanced research and development in the area of peripheral nerve repair for long gap nerve injuries, we are pleased to extend our existing product line to address an immediate clinical need in the area of neuroma formation at the terminal ends of injured nerves. Collagen Matrix is committed to enhancing its products and providing improved clinical solutions in 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- 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 orthopedic tissue regeneration applications. The Company currently manufactures collagen-based finished medical devices in the areas of neurosurgery, oral surgery, and orthopedic-spine surgery. More information about the Company can be found at www.collagenmatrix.com.
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