Biomerix has received FDA 510(k) clearance to market its Biomerix Ventral Hernia Repair Mesh, the latest addition to its portfolio of soft tissue repair devices.
The Ventral Hernia Repair Mesh features Biomerix Biomaterial on one side and a resorbable protective film on the other side. It is designed to promote tissue ingrowth and to minimise 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.
The Biomerix Ventral Hernia Repair Mesh is designed to provide a resorbable protective film on one side to act as barrier, minimising 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.
Kenneth Hayes, president and chief executive officer of Biomerix, said: “The FDA clearance of the Biomerix Ventral Hernia Repair Mesh represents the next generation in ventral and incisional hernia repair prosthesis.
“We believe the novel Biomerix Biomaterial has desirable scaffold features leading to successful repair outcomes, making it a compelling alternative to other synthetic biomaterials.”