Fremont, California -- US biomedical polyurethane materials group Biomerix Corp. has received the CE Mark for its Assure soft-tissue repair mesh, which is a composite mesh for reconstructing hernias and soft-tissue deficiencies as well as for temporary bridging of fascial defects.
The CE Mark allows Biomerix to distribute Assure throughout Europe, and supports certification in many other parts of the world that recognise the CE Mark for commercial distribution.
Assure is constructed of three distinct layers, the first of which is Biomerix Biomaterial. This is 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, while the third layer is a resorbable lactide caprolactone copolymer film designed to minimise tissue attachment to the device in case of direct contact with the viscera.
"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," said Kenneth Hayes, president and ceo of Biomerix Corp., in a 5 Jan company statement.
Assure is already available in the US after receiving a 510(k) clearance from the US Food and Drug Administration (FDA) in May 2010.