More good news for Boston Scientific’s coronary IVL tech
Boston Scientific’s new coronary intravascular lithotripsy (IVL) catheter appears to be both safe and effective for the treatment of severely calcified coronary artery disease (CAD), according to new late-breaking data presented at EuroPCR in Paris.
Boston Scientific first entered the IVL space when it acquired Bolt Medical in 2025. Its Seismiq IVL platform uses laser energy to target calcium with acoustic pressure waves and has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of peripheral artery disease. Now, the company is studying the technology’s potential to treat calcified coronary lesions during percutaneous coronary intervention (PCI) procedures.
A recent first-in-human analysis identified potential in Boston Scientific’s Seismiq 4CE Coronary IVL Catheter as a treatment for CAD. Now, researchers at EuroPCR have presented data from a larger study of 420 patients with severe CAD.
In the single-arm FRACTURE trial, freedom from major adverse cardiac events such as cardiovascular death, myocardial infarction and target vessel revascularization after 30 days occurred in 93.3% of patients. The goal at the start of the study was 86.2%. In addition, the procedural success rate was 93.7%; the team’s goal was a rate of 85.8%.
“As the prevalence of coronary artery disease and adoption of IVL therapy to address it continue to grow rapidly, data from this important trial will help advance our understanding of treatment for severely diseased, previously untreated coronary lesions and could help broaden the scope of coronary IVL treatment options over time,” Margaret McEntegart, MD, PhD, co-principal investigator of the FRACTURE trial and director of the complex PCI and CTO Programs at Columbia University Irving Medical Center, New York, said in a statement. "Notably, stents were successfully delivered in all patients treated, no deaths occurred, and only one patient underwent target vessel revascularization at the 30-day follow up, underscoring reassuring safety data for the Seismiq 4CE device.”
“Representing one of the fastest growing medical device segments in both peripheral and coronary care, IVL therapy can help address a critical level of coronary artery narrowing or blockage that poses a threat of heart attack, heart failure and other serious complications,” added Janar Sathananthan, MD, Boston Scientific’s chief medical officer of interventional cardiology therapies. "The data presented today serves as pivotal evidence to support our regulatory submission for the Seismiq 4CE catheter, which may provide physicians a new, differentiated coronary IVL device option to address severe calcium during the lesion prep phase of complex PCI procedures, potentially improving outcomes for these high-risk patients.”
The Seismiq 4CE Coronary IVL Catheter is not approved by the FDA.
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.