REPEL-CV Bioresorbable Adhesion Barrier - P070005
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: REPEL-CV Bioresorbable Adhesion Barrier
PMA Applicant: SyntheMed, Inc.
Address: 200 Middlesex-Essex Turnpike Suite 210, Iselin, NJ 08830
Approval Date: March 6, 2009
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf7/P070005a.pdf
What is it? 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.
How does it work? REPEL-CV prevents interconnection (adhesions) between two opposing surfaces, specifically between the chest wall and the pericardium (a membrane that covers the heart). As the body tries to heal after cardiac surgery, the natural response is to increase the number of fibroblasts at the injury site. Fibroblasts are cells that can turn into dense adhesions that surgeons have difficulty navigating through when a patient has to have a repeat surgery. The REPEL-CV interrupts this process of adhesion formation and reduces the severity of the adhesions.
When is it used? REPEL-CV is indicated for reducing the severity of post-operative cardiac adhesions in pediatric patients who are likely to require reoperation via sternotomy.
What will it accomplish? 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.
When should it not be used? There are no known contraindications for this device.
Additional information: The Summary of Safety and Effectiveness and Labeling will be available online.