Collagen Matrix Gains Clearance for Flexible Collagen Nerve Conduit

Oakland, N.J.-based Collagen Matrix Inc. has earned 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Flexible Collagen Nerve Conduit for management of peripheral nerve injuries at nerve ends in the foot to reduce the formation of painful neuroma. The product is hoped 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 John S. Gould, M.D., 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,” said Shu-Tung Li, Ph.D., Founder and CEO of Collagen Matrix. “Collagen Matrix is committed to enhancing its products and providing improved clinical solutions in the area of peripheral nerve repair.”

Collagen Matrix makes collagen- and mineral-based extracellular matrices for tissue and organ repair and regeneration.