Collagen Matrix Receives FDA Clearance For Nerve Injury Conduit

The U.S. Food and Drug Administration has granted 510(k) clearance to Collagen Matrix for its Flexible Collagen Nerve Conduit for management of peripheral nerve injuries at nerve ends found in the foot to reduce the formation of painful neuroma. The company said its product is the first to receive clearance for the treatment of neuroma formation at nerve ends.

Flexible Collagen Nerve Conduit is a resorbable, flexible type I collagen tubular matrix that serves both as an encasement for peripheral injury and protection of the neural environment. The device is designed to be an interface between the surrounding tissue and the nerve, thus preventing the ingrowth of scar tissue. The conduit is placed at the terminal end of a nerve to prevent neuroma formation. Collagen Matrix said patients suffering from pain caused by conditions such as Morton’s neuroma, amputations, or other nerve damage in the foot will benefit from its product.

Once hydrated, the product becomes a flexible collagen conduit with its crimped walls providing kink resistance to the tube. The resistance is particularly important for the natural outgrowth of the regenerating axons of the injured proximal nerve stump without hindrance.

The FDA clearance was based on the results of a study conducted by Dr. John S. Gould of the University of Alabama at Birmingham, wherein the product demonstrated clinical benefit. Fifty patients were successfully treated of painful single or multiple neuromas through excision and implantation of the resected nerve end into the Flexible Collagen Nerve Conduit.

Shu-Tung Li, Ph.D., Founder and CEO of Collagen Matrix, said, “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.”