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 University Medical Center. Disrupt CAD III’s first patient was enrolled last week by Dr. Richard Shlofmitz of Roslyn, N.Y.’s St. Francis Hospital.
“After previously using the peripheral IVL technology – Shockwave M5 – to enable transfemoral access for TAVR as well as for mechanical cardiac support and hearing the enthusiasm from Europe about coronary IVL, we are very excited to investigate the clinical potential of the coronary technology in the United States,” Kereiakes said in prepared remarks. “This therapy holds tremendous potential from a safety perspective for patients and an ease of use perspective for physicians – if coronary IVL is shown to be safe and effective, it could be a game changer for the way we treat calcified arteries today.”
“Having treated nearly 100 patients with IVL since its European launch, the benefits for treating complex patients are evident. I am delighted to be a part of this important global trial to introduce my U.S. interventional colleagues to this novel technology. IVL is easy to use and has been a huge advancement for our management of calcified lesions,” Hill added. “I think U.S. interventionalists will recognize the simplicity and ease of use of the IVL system and will appreciate its ability to be rapidly deployed in any cath lab. I have no doubt that IVL is poised to become the key differentiating technology compared to other calcium modification tools.”