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SyntheMed reports positive results for Repel open-heart trial
By Elaine Rigoli
Tampa, Fla., Sept. 6 - SyntheMed, Inc. said its multi-center, randomized, masked pivotal clinical trial of Repel-CV in neonatal patients who underwent staged, open-heart surgical procedures met its primary clinical endpoint based on the level of reduction in the extent and severity of adhesions.
Repel-CV is a bioresorbable film designed to be placed over the surface of the heart at the conclusion of surgery to reduce the formation of post-operative adhesions (scar tissue), the company said in a news release.
The Iselin, N.J.-based biomaterials company said more than 70% of patients were completely free of clinically significant adhesions, the most severe grade of adhesions measured, as compared to less than 30% in the control patients.
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