Shockwave Medical launches U.S. pivotal for coronary lithotripsy

Shockwave Medical said today that it launched a U.S. pivotal trial for its coronary lithotripsy device, which is designed to prepare heavily calcified coronary lesions for stenting. The technology uses sonic pressure waves to fracture intimal and medial calcium without damaging arterial tissue, Santa Clara, Calif.-based Shockwave said. Last April the Shockwave S4 catheter, designed to similarly treat peripheral arteries, won CE Mark approval in the European Union. The company raised $35 million in October 2017. The two-year, 392-patient Disrupt CAD III study is designed to evaluate the safety and effectiveness of the Shockwave with the Shockwave C2 catheter in de novo, calcified, stenotic coronary arteries prior to stenting. The primary safety outcome is the rate of freedom at 30 days from major adverse cardiac events, defined as cardiac death, myocardial infarction or target vessel revascularization. The primary efficacy endpoint is the procedural success rate, defined as stent delivery with a residual stenosis of less than 50% and without in-hospital MACE, according to the company and ClinicalTrials.gov. The estimated primary completion date is August 2020, with an estimated study close in July 2022. The co-principal investigators are Drs. Dean Kereiakes of Cincinnati’s Christ Hospital Heart & Vascular Center and Jonathan Hill of London’s King’s College Hospital. The study’s chairman is Dr. Gregg Stone of New York’s Columbia Univers...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Clinical Trials Featured Shockwave Medical Source Type: news