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Material Helps Heart Surgeons Second Time Around

You know how annoying it is when you have gum stuck to your shoe? How it stretches and can be quite cumbersome to remove? Well, surgeons experience a similar problem when performing secondary heart procedures on patients.

Adhesions (fibrous bands of scar tissue) that form in the chest cavity after an initial heart surgery make it difficult and dangerous, due to the formation of new blood vessels interwoven into the tissue, to reach the heart. A bioresorbable polymer antiadhesion barrier, developed by SyntheMed Inc. (Iselin, NJ) is designed to help prevent the formation of the scar tissue. Surgeons can apply the clear film, called Repel CV, over the heart after surgery, and the material is absorbed by the body within 28 days. Data from FDA-regulated trials using the product revealed that a high percentage of patients were free of "clinically-significant adhesions." FDA's Circulatory System Devices Advisory Panel recently recommended the approval of the adhesion barrier in patients 21 and younger. It recommended that more safety data would be needed to expand the use to include adults. The company's president, Robert Hickey, told MD&DI that he expects Repel CV to be on the U.S. market at the end of this year or sometime in 2008.

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