FDA Approves Adhesion Barrier for Pediatric Cardiac Patients
SyntheMed, Incorporated received FDA approval for their adhesion product, the REPEL-CV Adhesion Barrier, that is indicated for pediatric patients who are likely to undergo secondary open heart surgery. The approval was noted on the PR Newswire.
The product is a bioabsorbable adhesion barrier film that is placed directly on the heart muscle after open heart surgery. The object of the barrier is to reduce both the severity and extent of scar tissue that develops in between the surface of the heart and surrounding tissue surfaces. The product is placed to reduce the adhesion development and then naturally degrades and clears from the body.
Development of scar tissue, or adhesions, is a known complication of this procedure. It becomes a challenge particularly for those patients who must undergo a second open heart procedure. In particular, adhesions complicate visualization of and access to the heart. Adhesions require removal in order to successfully complete a second heart procedure, which is a time consuming endeavor. Time to remove such may require an additional hour of surgical time, which increases the patient’s risks associated with anaesthesia.
Among the half million patients who undergo open heart surgery every year, almost 15 to 20 percent are undergoing such as a second procedure. A study conducted by SyntheMed evaluated the outcomes among patients who had a REPEL-CV used. Over 70 percent of those patients did not develop adhesions. Additional details are available on the company’s website detailing the product.
Following collection of additional information on product safety, the FDA suggested that this product may receive an expanded indication for use in the adult population.
September 24, 2007 Related topics: Product Approval & Certification, New Technology & Innovation, Pediatrics, Cardiology