Shockwave Medical’s new coronary IVL catheter, now twice as fast, impresses after 30 days
Shockwave Medical, a part of Johnson & Johnson MedTech, has shared early data on a new intravascular lithotripsy (IVL) catheter designed to deliver treatments to the coronaries twice as fast as the company’s current offerings. Researchers shared the analysis in JACC: Cardiovascular Interventions, an American College of Cardiology journal.[1]
Shockwave Medical, acquired by Johnson & Johnson for $13 billion in 2024, is one of the leading names in IVL technology. The company’s current coronary IVL catheter delivers ultrasonic acoustic pressure waves to severely calcified coronary artery lesions at a rate of one pulse per second. The new model at the heart of this analysis, however, was built to deliver 10 pulses in 5 seconds to reduce balloon inflation time and boost efficiency.
Disrupt CAD DUO was a multicenter clinical trial funded by Shockwave Medical. Researchers enrolled 145 patients with a mean age of 70.5 years old. All patients were treated with Shockwave Medical’s new 2-Hz IVL platform.
While 68% of patients were men, 30% presented with a diagnosis of diabetes. The mean lesion length was 27.7 mm, mean reference vessel diameter (RVD) was 3.2 mm and mean calcification length was 39.6 mm.
The study’s primary effectiveness endpoint—procedural success and no in-hospital adverse cardiovascular events—occurred in 98.6% of patients. Meanwhile, the primary safety endpoint—freedom from 30-day major adverse cardiovascular events or target vessel revascularization—occurred in 97.9 % of patients. According to the study’s authors, these outcomes were noninferior to a matched cohort of patients treated with Shockwave Medical’s 1-Hz IVL platform that is currently on the market.
IVL-induced ventricular capture was more common than with currently available catheters, the group added, but IVL was not linked to any clinically significant cases of hypotension or arrhythmia.
“Ongoing follow-up will further inform longer-term safety and durability of 2-Hz IVL therapy in calcific coronary artery disease,” wrote first author Rhian E. Davies, DO, an interventional cardiologist with WellSpan Health, and colleagues.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.