Early boost for Life Medical's anti-adhesion product:
This article was originally published in Clinica
Executive Summary
Life Medical Sciences has taken an early, but important, step closer to becoming the first to gain US approval to market an anti-adhesion product for use in cardiac surgery. A US feasibility trial of the company's REPEL-CV bioresorbable adhesion barrier for reducing post-operative adhesion formation in cardiac surgical procedures has provided preliminary data to support the product's safety and effectiveness, says the Ocean Port, New Jersey firm. Life Medical has submitted the results and a proposed multicentre, pivotal clinical trial protocol to the FDA. The proposed trial is expected to form the basis for obtaining FDA approval to market the product.