Shockwave Medical said today it enrolled the 1st patient in the Disrupt PAD III trial of its Lithoplasty system, aiming to explore the system’s effectiveness at treating heavily calcified lesions in the leg compared to traditional angioplasty.
The company’s Lithoplasty device is designed to use intermittent lithotripsy pulses to disrupt superficial and deep vascular calcium and an angioplasty balloon to expand blockages at low pressures to restore blood flow.
The 334-patient trial will have a primary goal of achieving less than 30% residual stenosis without the need for stenting, and all patients who do not receive a stent will be treated with a drug-coated balloon, the Fremont, Calif.-based company said.
“We are very excited to be the 1st to treat a U.S. patient in the global study of this cutting edge technology for patients with claudication or pain in the legs due to leg artery blockages. The Shockwave Medical Lithoplasty device, if proven as a result of this clinical trial, will be a “game changer” in the treatment of patients with PAD, allowing for low pressure, controlled expansion of blocked artery and potentially less risk for internal tearing of the artery and need for implanting permanent metal stents,” PinnacleHealth CardioVascular Institute site primary investigator Dr. William Bachinsky said in a press release.
Last November, Shockwave Medical said it raised a $45 million Series C round for the Lithoplasty device it developed to treat calcified vascular lesions.
The company said Sectoral Asset Management led the round, joined by new backer T. Rowe Price and existing investors Sofinnova Partners, Venrock, RA Capital, Deerfield, Ally Bridge Group and others.