Genzyme's surgical mesh gets US clearance:
This article was originally published in Clinica
Executive Summary
Genzyme Surgical Products has received 510(k) clearance from the US FDA to market its Sepramesh Biosurgical Composite for use in hernia repair procedures. The surgical mesh is designed to be sutured in place along the abdominal wall providing support and strength to the hernia repair. Sepramesh contains a bioresorbable barrier that separates the mesh from underlying tissue and organ surfaces to minimise attachment to the mesh. This offers significant advantages over traditional mesh products, the Cambridge, Massachusetts-based company said.