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The Bolt Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, popliteal, and infra-popliteal arteries. Not for use in the coronary, carotid, or cerebral vasculature.

The Bolt Intravascular Lithotripsy (Bolt IVL) System is a proprietary balloon catheter and console designed to enhance percutaneous transluminal angioplasty by delivering calcium disrupting lithotripsy prior to balloon dilatation at low pressures. The application of lithotripsy mechanical pulse waves alters the structure of an occlusive vascular deposit (stenosis) allowing low-pressure balloon dilatation of the stenosis. The Bolt IVL catheter is delivered through the peripheral arterial system of the lower extremities to the lesion site. The balloon is partially inflated and the lithotripsy emitters generate pulsatile mechanical energy within the balloon at the target treatment site allowing subsequent dilatation of a peripheral artery stenosis using low balloon pressure. The Bolt IVL Catheter is a single-use device supplied sterile to the customer. The Bolt IVL console delivers energy through the integrated catheter cabling to the emitters located inside the catheter balloon. The Bolt IVL Console is a non-sterile, reusable device.