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Biomerix Ventral Hernia Repair Mesh Receives FDA 510(k) Clearance

June 30, 2010 By Bio-Medicine.Org

FREMONT, Calif., June 30 /PRNewswire/ — Biomerix
Corporation announced today that it has received U.S. Food and Drug
Administration (FDA) 510(k) Clearance to market its Biomerix
Ventral Hernia Repair Mesh, the latest addition to its innovative
portfolio of soft tissue repair devices. The Biomerix Ventral
Hernia Repair Mesh, with two distinctly different sides, is the
first and only device featuring the Biomerix Biomaterial™ on
one side, designed to promote tissue ingrowth, and a resorbable
protective film on the other side, designed to minimize tissue
attachment to the device in case of direct contact with the
viscera. It is indicated for use in hernias and soft tissue
deficiencies and for the temporary bridging of fascial defects.

More than 400,000 people suffer from ventral hernias in the U.S.
today. A ventral hernia is a lump in the abdomen, usually a tissue
bulge or a small area of swelling. Ventral hernia is also referred
to as an incisional hernia, since it can occur in the area of any
prior surgical incision. An aging population and a growing number
of obese patients are contributing to the rising incidence of
ventral hernias. Current product solutions are unable to address
the high recurrence rates and the increased risk of adhesion
formation commonly associated with ventral hernia repair. The
Biomerix Ventral Hernia Repair Mesh is constructed to support
tissue ingrowth. The state-of-the-art design provides a resorbable
protective film on one side to act as barrier, minimizing the risk
of adhesions to the device. By incorporating the Biomerix
Biomaterial™ platform, the Ventral Hernia Repair Mesh’s soft
and pliable design offers surgeons conformability for acute
performance in both open and laparoscopic procedures.

“The FDA clearance of the Biomerix Ventral Hernia Repair Mesh
represents the next generati

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SOURCE

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