MitraPatch Mitral Valve Repair System

The MitraPatch™ Mitral Valve Repair System is a single-use permanent implant made of expanded polytetrafluoroethylene (ePTFE) designed to repair mitral valves compromised by chordae tendinae prolapse or rupture. It connects the papillary muscle to the mitral valve leaflet, functioning as an artificial chordae tendinae to prevent valve leaflet prolapse and restore normal valve function.

The device is made of nonabsorbable ePTFE in a monomembrane configuration with attachment planes and suture holes, requiring no needles and allowing adjustable positioning at the leaflet attachment. The predicate device (Chord-X) uses monofilament ePTFE sutures with multiple size options and pre-supplied pledgets. Both devices are sterilized by ethylene oxide and achieve 10⁻⁶ sterility assurance level.

ISO 10993-3 (genotoxicity), ISO 10993-4 (hemocompatibility), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and intracutaneous reactivity), ISO 10993-11 (acute systemic toxicity and pyrogenicity), ISO 10993-18 (chemical characterization), ISO 11135 (sterilization), ASTM 1980, ASTM 1929, ASTM 4169, ASTM F88 (shelf life and performance), and USP <85> (bacterial endotoxin).

The MitraPatch has the same intended use and anatomical location (mitral valve chordae tendinae repair) as the predicate Chord-X device, uses the same material (ePTFE), operates by the same mechanism (neochord replacement), and employs the same sterilization method. Non-clinical testing demonstrated equivalent tensile strength, creep resistance, implant capture force, and performance, with preclinical animal studies showing no inflammation, migration, or deterioration, establishing substantially equivalent safety and effectiveness.