FDA To Review Application For REPEL-CV
SyntheMed has been informed by the US Food and Drug Administration that it will review the Company's Pre-market Approval application for REPEL-CV Adhesion Barrier.
REPEL-CV is a bioresorbable film designed to be placed over the surface of the heart at the conclusion of an open heart surgical procedure to reduce the formation of post-operative adhesions (scar tissue). The Advisory Panel will be comprised of healthcare professionals including cardiac surgeons who will review the clinical merits of REPEL-CV and provide their recommendation regarding approval for sale in the US market.
Robert P. Hickey, President and Chief Executive Officer, SyntheMed, Inc. commented, "We are very pleased with the FDA's decision to convene an Advisory Panel meeting to review our PMA filing. We believe that our clinical data demonstrates sufficient safety and effectiveness to warrant marketing approval. We have assembled a team including clinical investigators and other prominent cardiac surgeons to join us in presenting our data to the panel."
Adhesions, or scar tissue, occur after virtually all open-heart surgical procedures, often resulting in the heart becoming attached to the sternum and other surround tissue surfaces. The presence of adhesions represents a prevalent and serious complication in secondary surgical procedures, increasing the length, cost and risk of the surgical procedure. There are approximately 500,000 open heart surgeries performed annually in the United States, and another 350,000 procedures estimated throughout the European Union. In both markets, approximately 15-20 percent of these surgeries are secondary procedures.
REPEL-CV is a bioresorbable adhesion barrier film designed to be placed over the surface of the heart at the conclusion of an open-heart surgical procedure to reduce the extent and severity of adhesions that form between the surface of the heart and the inner surface of the sternum following the surgical procedure. REPEL-CV is designed to provide the therapeutic benefit and then degrade so that it is cleared from the body. A CE Mark was granted in August 2006 and REPEL-CV is marketed through a network of independent distributors in international markets. REPEL-CV represents the first in a series of anti-adhesion products under development that are based on the Company's proprietary polymer technology.