Biomerix Corporation announced today that it has received CE Mark approval for its REVIVE™ soft tissue repair mesh allowing for the marketing of REVIVE in all European Union member (EU) states. REVIVE received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in January 2009.
REVIVE is constructed of the Biomerix Biomaterial™, a proprietary, biointegrative synthetic tissue scaffold. This unique structure is designed to play a role similar to that of the body's extracellular matrix, supporting organized tissue ingrowth. The device is designed for repair and reinforcement in a variety of soft tissue procedures such as inguinal hernias.
Over 700,000 inguinal hernia repair procedures are performed annually in Europe. Inguinal hernias occur when soft tissue, usually part of the intestines, protrudes through a weak point or tear in the lower abdominal wall. Synthetic mesh is commonly used to reinforce the repair and support the surrounding tissue. REVIVE is designed to facilitate robust tissue ingrowth, while minimizing the scarring response typically associated with implantation of a mesh. Mesh contraction and intense scarring can lead to persistent groin pain. Initial feedback from users of REVIVE has confirmed excellent ease of use and conformability to the anatomy. The soft, pliable nature of the mesh easily adapts to the anatomy allowing for easy delivery, positioning and fixation of the mesh.
"This latest approval represents another important milestone in Biomerix's plans to develop innovative products based on its proprietary materials and capabilities," said Kenneth G. Hayes, President and CEO of Biomerix Corporation. "REVIVE will be distributed in the EU by Medline Industries pursuant to our exclusive distribution agreement."
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