Abstract
California-based Biomerix Corporation has announced that it has received CE Mark approval for its ASSURE soft tissue repair mesh, a novel composite mesh intended for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. This approval allows Biomerix to distribute ASSURE throughout Europe and support certification in many other parts of the world that recognize the CE Mark for commercial distribution purposes. The company claims to be a leader in the development and manufacturing of innovative non-absorbable and bioresorbable three-dimensional, open-cell, resilient elastomeric polyurethane biomaterials (!) and has unusually gained FDA approval well in advance of seeking a CE mark for its product.
The product
ASSURE is constructed of three distinct layers, each layer providing an important function in the repair of a hernia or soft tissue deficiency. The first layer consists of the Biomerix Biomaterial, a proprietary, biointegrative synthetic polyurethane tissue scaffold designed to play a role similar to that of the body’s extracellular matrix, a biological structure that supports tissue repair and regeneration. The second layer is a knitted polypropylene monofilament mesh which provides mechanical support for a strong, durable and flexible repair. The third layer consists of a resorbable lactide caprolactone copolymer film designed to minimize tissue attachment to the device in case of direct contact with the viscera.
Company comments
“ASSURE’s distinctive multi-layered design reflects extensive market research to address patient comfort and surgeon ease-of-use in open and laparoscopic (minimally invasive) hernia repair procedures. The device incorporates the unique properties of a biologic tissue scaffold to support tissue regeneration with the best properties of a synthetic biomaterial in terms of its strength and durability,” said Kenneth G. Hayes, President and CEO of Biomerix Corporation.
“ASSURE is already available in the United States after receiving a 510(k) clearance from the U.S. Food and Drug Administration (FDA) in May 2010. We are thrilled with the initial US experience to date and believe that ASSURE will provide substantial clinical benefits to patients.”
The company does not comment about its commercialisation plans for the product outside the United States at this time.
Source: Biomerix
published: January 6, 2012 in: Approval/Clearance, General Surgery, Plastic/Reconstructive, Regulatory