REPEL-CV Bioresorbable Adhesion Barrier

PMA Applicant    : SyntheMed, Inc.
Address              : 200 Middlesex-Essex Turnpike Suite 210, Iselin, NJ 08830
Approval Date     : March 6, 2009

REPEL-CV Bioresorbable Adhesion Barrier is a single use, synthetic, bioresorbable polymeric film composed of poly-lactic acid (PLA) and polyethylene glycol (PEG). PLA and PEG are used in other types of resorbable medical devices such as bone screws and sutures. This film is designed to provide a temporary barrier within the chest cavity that prevents adhesions from forming.

REPEL-CV was shown to be effective in reducing the severity of post-operative cardiac adhesions. In the clinical study, 21% of the investigational surgical site for all patients consisted of severe adhesions in the group that received the REPEL-CV compared to 47% of the investigational surgical site for all patients in the group that did not receive the REPEL-CV. Mediastinitis was one of the adverse events observed in the treated patients.

Visit : http://www.fda.gov/cdrh/mda/docs/P070005.html