AtriClip PRO-Mini LAA Exclusion System (PROM)

The AtriClip PRO-Mini LAA Exclusion System is a single-use, sterile, self-closing implantable clip preloaded on a disposable clip applier. It is used to exclude the left atrial appendage of the heart during cardiac surgery under direct visualization, electrically isolating the LAA to reduce stroke risk. The clip is available in lengths of 35, 40, 45, and 50 mm to accommodate different LAA sizes.

The PRO-Mini device is substantially identical to the predicate FLEX-Mini in clip design, materials, and operating mechanism. Both use the same AtriClip Mini (AOD3) with knit braided polyester contact surface and uniform pressure application. The PRO-Mini applier components (stainless steel jaws, shaft; polycarbonate handle) match the reference PRO2 device. All devices use gamma irradiation sterilization, achieve 10⁻⁶ SAL, employ biocompatible materials assessed per ISO 10993-1, and are sterile single-use disposables.

ISO 10993-1 biocompatibility assessment. Non-clinical bench testing included mechanical testing, reliability testing, tissue testing, and dose audit testing, but specific ISO, IEC, or ASTM standard citations are not provided in this summary.

The PRO-Mini is substantially equivalent because it maintains identical intended use and indications, employs the same clip design and operating principle as the predicate FLEX-Mini, uses materially and functionally equivalent applier components matching the reference PRO2 device, and underwent comparable verification and validation testing that met predetermined acceptance criteria and raised no new safety or performance issues. The device differs only in its external form factor while preserving all functional and performance characteristics of previously cleared devices.