D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter

The D-Kutting LL Peripheral Scoring Balloon Dilatation Catheter is an over-the-wire catheter with a non-compliant balloon featuring three longitudinal scoring elements for percutaneous transluminal angioplasty (PTA) in peripheral blood vessels. It is indicated for treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae and peripheral vasculature, but not for coronary use.

The device has a non-compliant balloon with three triangular-cross-section scoring elements attached by adhesive and nitinol wire, radiopaque marker bands on the inner lumen, a tapered tip, and lubricious coating. It is offered in balloon diameters 2.5–7.0 mm, lengths 20–150 mm, catheter lengths of 90, 135, or 150 cm, and is compatible with 0.014″ or 0.018″ guidewires. Design, materials, dimensions, and rated burst pressure (RBP) differ from the predicate but operate on equivalent principles.

EN ISO 11135:2014 for ethylene oxide sterilization validation; FDA Guidance Document on Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters (April 14, 2023). Biocompatibility testing follows ISO standards for cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity, and hemocompatibility.

The subject and predicate devices share the same technological foundation—both are over-the-wire cutting/scoring balloon catheters with three longitudinal scoring elements for peripheral PTA. Although materials, dimensions, and RBP differ, comprehensive bench testing (balloon compliance, torque, flexibility, scoring performance), biocompatibility testing (cytotoxicity through hemocompatibility), and animal studies (acute and 30-day chronic) demonstrated that these differences do not raise new safety or effectiveness questions. The subject device's in vivo performance was non-inferior to the control device.