Aperta NSE PTA Balloon Dilatation Catheter

The Aperta NSE PTA Balloon Dilatation Catheter is an over-the-wire catheter used for percutaneous transluminal angioplasty (PTA) in peripheral arteries (iliac, femoral, popliteal, infra-popliteal) and arteriovenous dialysis fistulae. It features protruding polymer elements parallel to the balloon to aid dilation of stenotic lesions difficult to expand with conventional balloons, and is also indicated for treating in-stent restenosis. The device is explicitly contraindicated for coronary and neuro-vasculature use.

Compared to the predicate device, the subject device includes longer balloon lengths of 100 and 150 mm (versus 40 mm) and reverses the radiopaque marker configuration: two markers at the distal end and one at the proximal end, versus one distal and two proximal on the predicate. The subject device maintains equivalent design, materials, chemical composition, and principle of operation as the predicate.

Not stated in this summary. The document references compliance with the FDA Guidance Document titled 'Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters' issued April 14, 2023, but does not cite specific ISO, IEC, or ASTM consensus standards.

The technological differences (longer balloons and reversed marker positions) do not raise new safety or effectiveness questions because comprehensive bench testing (balloon compliance, fatigue, burst pressure, torque, flexibility), biocompatibility testing (cytotoxicity, sensitization, hemocompatibility), and simulated use all met acceptance criteria. The extended balloon length enables treatment of longer lesions without changing the fundamental mechanism of action, and the marker repositioning serves the same localization purpose. Since indications for use are identical and non-clinical testing demonstrates equivalence in performance and safety, the subject device is substantially equivalent to the predicate.