A meeting of the Circulatory System Devices Panel was held on September 19, 2007. The Panel discussed the submission, made several specific recommendations, and voted on the premarket approval application (P070005) for the SyntheMed, Inc. REPEL-CV Bioresorbable Adhesion Barrier Film.
The sponsor was seeking the following indications for use statement for the device: REPEL-CV is a surgical adjuvant indicated for reducing the incidence, severity and extent of post-operative adhesion formation in patients undergoing cardiac surgery.
The REPEL-CV Bioresorbable Adhesion Barrier is a single use, synthetic, bioresorbable polymeric film composed of poly-lactic acid (PLA) and polyethylene glycol (PEG), polymers used extensively in implantable, absorbable medical devices. The REPEL-CV provides a temporary barrier to mechanically separate potentially opposing surfaces from interconnecting with each other via fibrin bands (fibrinous adhesions) during the early phase of tissue repair. By placing REPEL-CV over the traumatized tissue surfaces, the formation of the interconnecting fibrinous bands between opposing surfaces is prevented and the development of fibrous adhesions is reduced or prevented.
The critical intrinsic properties of REPEL-CV are that it maintains its barrier property during the early phase of the healing process, when fibrin is formed. Once fibrinogenesis is completed and the formation of the interconnecting fibrinous bands has been blocked, the barrier begins to fragment and degrade (resorb) over time. REPEL-CV was designed to be absorbed from the site of implantation within 28 days.
The sponsor presented data from their pivotal study, which was a multi-center, randomized, evaluator-masked, parallel comparative study. The objectives of the study were to determine the safety and effectiveness of REPEL-CV for reducing post-operative adhesions in pediatric patients undergoing cardiothoracic surgery.
This trial was conducted in 15 centers with a total of 144 pediatric patients. Two of the 15 centers had only 1 to 4 patients. Four centers had 14 to 19 patients. There were a total of 142 patients enrolled in the study after 2 patients were not enrolled due to protocol violations.
Following presentations by the sponsor and the FDA, and after extensive deliberation, the Panel voted (8-3) in favor of “Approvable with Conditions.” The recommended conditions of approval are summarized as follows:
- Removal of the contraindication that prevents use of the device in patients with left ventricular assist devices;
- Modification of the indications statement to remove “incidence and extent;”
- Modification of the indications statement to limit use of the device to a pediatric population as defined by FDA;
- Modification of the indications statement to specify that patients receiving the device would have a high likelihood of a reoperation; and
- Development of a post-approval study to evaluate long-term safety and effectiveness.
Contact: James Swink, Executive Secretary,
(240) 276-4179 James.Swink@fda.hhs.gov
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