May 26 2010
SyntheMed, Inc. (OTC Bulletin Board: SYMD), a biomaterials company engaged in the development and commercialization of anti-adhesion products, today announced that REPEL-GYN™, the company's bioresorbable adhesion barrier film for the reduction of adhesions following gynecologic surgery, has received CE Mark approval in the European Union (EU).
CE Mark approval signifies that REPEL-GYN has met the essential requirements of the European Union Medical Devices Directive and enables the company to begin marketing the product to reduce the incidence, severity and extent of post-operative adhesion formation in patients undergoing gynecologic surgery.
The formation of adhesions (scar tissue) between organs in the pelvic cavity is a frequent, undesirable result of gynecologic surgery. Pelvic adhesions can cause the patient to endure chronic pain, small bowel obstruction and infertility. The presence of adhesions is also a complicating factor in repeat caesarian sections. There are an estimated 2 million gynecologic procedures performed annually in the EU and other international markets in which the patients are at risk of developing adhesion-related complications.
Robert P. Hickey, President and CEO, SyntheMed, Inc., stated, "We are very pleased to have received regulatory approval to expand the use of our proprietary bioresorbable polymer film in the EU markets. REPEL-GYN is similar to REPEL-CV® Adhesion Barrier which is currently marketed internationally for use in all cardiac surgical procedures and in pediatric cardiac surgery in the United States. We are currently evaluating our options on the marketing of REPEL-GYN throughout the EU either through a corporate partner or an independent distribution network."
Source: http://www.synthemed.com/