PeriBeam® Pericardial Membrane

PeriBeam® Pericardial Membrane is an ion-irradiated, expanded polytetrafluoroethylene (ePTFE) membrane used for reconstruction or repair of the pericardium. It functions as a temporary or permanent prosthesis to cover pericardial defects and is held in place by surgical sutures.

Both PeriBeam® and the predicate PRECLUDE® Pericardial Membrane are made of ePTFE with nearly identical technological characteristics. The key difference is that PeriBeam® features ion-beam etching on one surface designed to create an adhesive surface for the pericardium, whereas the predicate lacks this modification. Materials, dimensions, thickness, sterilization method, packaging, and biological safety are otherwise similar.

ISO 2859-1 (tensile and suture strength), ISO 13938-1 (burst strength), JIS L1096 8.18 (burst strength equivalent), ISO 10993 (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, subacute toxicity, implantation, genotoxicity, chronic toxicity, carcinogenicity, hemolysis), JIST 0186-1:2010 and ISO 17665-1:2006 (sterilization), ISO 11135, ISO 11737-1, ISO 11607-1:2019, ASTM F1980, ASTM F2096, and ASTM F88 (packaging and shelf-life validation).

PeriBeam® is substantially equivalent because it shares the same ePTFE material composition, identical indications for use (pericardial reconstruction/repair), and equivalent performance characteristics as the predicate device. Although ion-beam etching is added to enhance surface adhesion, comprehensive performance testing including tensile strength, suture strength, fatigue, burst strength, and fibrin glue compatibility demonstrates mechanical safety. Animal implantation studies and extensive ISO 10993 biocompatibility testing confirm the modification does not introduce new safety risks, making the device appropriate for the same clinical application as its predicate.