Bolt Intravascular Lithotripsy (IVL) System

The Bolt Intravascular Lithotripsy (IVL) System is a balloon catheter and console that enhances peripheral artery angioplasty by delivering pulsatile mechanical energy (lithotripsy) to calcified lesions before balloon inflation at low pressure. It is intended for treatment of calcified stenotic lesions in peripheral arteries (iliac, femoral, popliteal, and infra-popliteal), but not for coronary, carotid, or cerebral use.

The Bolt IVL System incorporates substantially equivalent design, dimensional, and performance specifications to the predicate Shockwave Lithoplasty System, including identical sheath and guidewire compatibility, usable catheter length, balloon diameters and lengths, and treatment and nominal pressures. Both systems use catheters delivering acoustic energy via cable to a console with the same operating principles and intended use.

ISO 10993-1:2020 (Biological evaluation of medical devices); 21 CFR 58 Good Laboratory Practices. Testing included catheter mechanical properties (diameter, tensile strength, kink resistance, torsional strength, compliance, fatigue), balloon performance (inflation/deflation time, burst strength), pushability, trackability, fluoroscopic visibility, particulate evaluation, console hardware and electrical performance, electromagnetic compatibility, and software verification/validation.

The Bolt IVL System shares the same intended use, mechanism of action, and similar technological characteristics as the predicate device (Shockwave Lithoplasty System K161384). Both deliver acoustic energy to peripheral arteries via catheter-console systems for lithotripsy-enhanced angioplasty. Any design differences were evaluated through comprehensive bench testing, chronic porcine animal studies, and two prospective clinical trials (RESTORE ATK and RESTORE BTK) that demonstrated safety and effectiveness meeting or exceeding performance goals, with no new safety or effectiveness questions identified.