FDA Clears Shockwave Medical’s Lithoplasty System

The FDA grants clearance to Shockwave Medical’s Lithoplasty System, which is designed for the treatment of calcified plaque in patients with peripheral artery disease (PAD).

The device is designed to selectively target hardened calcium in patients with cardiovascular disease. Recurrent sound wave pulses disrupt vascular calcium, and then an integrated angioplasty balloon expands blockage areas at low pressures to restore blood flow.

PAD affects nearly 9 million people in the U.S. — Cynthia Jessup