FDA Panel to Review Device that Prevents Scar Tissue

SyntheMed, of Iselin, NJ, today got word that an FDA panel will advance the first anti-adhesion product in what the company estimates is a $2 billion portfolio.

On September 19, FDA’s Circulatory System Devices Advisory Panel will review SyntheMed’s pre-market approval application for REPEL-CV Bioresorbable Adhesion Barrier, for use in open-heart surgical procedures. The device is placed over the heart at the end of the surgery and is intended to block the transmission of fibrin that can lead to the formation of adhesions, or scar tissue. Adhesions connect tissues or organ surfaces that are not normally joined. They can cause significant complications in secondary surgical procedures, increasing the length, cost and risk of the procedure.

In September 2006, SyntheMed announced the results of a pivotal trial in which REPEL-CV was shown to provide a significant reduction in adhesions. The product is CE Marked, and SyntheMed has already established a network of independent distributors throughout Europe and South East Asia.

SyntheMed has a healthy pipeline of products under development. In addition to REPEL-CV, anti-adhesion products are in development for use in gynecologic, general and spine surgery. The company is also exploring the use of its materials in site-specific drug delivery — REPEL-AFIBTM is a drug delivery vehicle designed to prevent the onset of atrial fibrillation following open heart surgical procedures.

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