A Medical Device Daily
SyntheMed (Iselin, New Jersey) reported that the FDA has accepted its pre-market approval application for Repel-CV adhesion barrier for review. 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 post-operative adhesions.
"Adhesions pose serious health risks to patients who have cardiac reoperations as well as result in higher costs for the hospitals where these procedures are performed," said Robert Hickey, president/CEO of SyntheMed. "Our clinical trial results have demonstrated that Repel-CV has the potential to reduce [operating room] time, patient exposure to anesthesia and other complications associated with cardiac adhesions."
In September 2006, SyntheMed reported positive efficacy results from its multi-center, randomized, masked pivotal clinical trial of Repel-CV in neonatal patients who underwent staged, open-heart surgical procedures, conducted at 15 U.S. pediatric cardiac surgery centers and enrolling 144 neonatal patients. Surgeons used a four-point grading system to determine the extent and severity of adhesions in the patients.
More than 70% of the Repel-CV treated 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, with a p value < 0.0001. In the primary clinical endpoint assessment, the mean extent of clinically-significant adhesions in the control patients was 2.5 times greater than in the Repel-CV patients, with a p value = 0.0005.
Repel-CV is marketed in the European Union and in several Southeast Asian countries.