New coronary IVL tech from Boston Scientific impresses in first-in-human study
A new intravascular lithotripsy (IVL) system from Boston Scientific may be an effective treatment option for patients with severely calcified coronary lesions, according to a new first-in-human study published in Circulation: Cardiovascular Interventions.[1]
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. Until now, however, there has been no data on the technology’s potential to treat coronary lesions during percutaneous coronary intervention (PCI) procedures.
This first-in-human analysis of the Seismiq 4CE Coronary IVL Catheter included 41 patients with a mean age of 71.7 years old. All patients presented with stable, unstable, or silent ischemia and were scheduled to undergo PCI. The mean baseline reference vessel diameter was 2.9 mm, mean lesion length was 17.1 mm and median calcified length was 26.3 mm.
The device success rate was 97.4% due to once instance when the target lesion could not be properly crossed by the IVL catheter. The median number of pulses was 120. No perforations, abrupt closures or no-reflow after IVL were reported.
The primary safety endpoint—freedom from major adverse cardiovascular events after 30 days—was 90.2% due to a small number of patients experiencing a periprocedural myocardial infarction. The procedural success rate was 89.5%, again due to those myocardial infarctions.
“In this first-in-human study, we explored the safety and efficacy of a novel coronary IVL system using similar criteria as currently available IVL technology,” wrote first author Matthew J. Price, MD, a veteran interventional cardiologist and director of the cath lab at Scripps Clinic, and colleagues. “We demonstrate that the use of this catheter in severely calcified coronary stenoses is feasible and results in substantial improvement in luminal area, excellent stent expansion, and high rates of procedural success.”
Price et al. also reviewed some potential benefits of the Seismiq system’s optical fibers and tungsten emitters.
“Laser and fiber-optic-based IVL may have several advantages over electrical, copper-wire-based arc discharge systems,” the group wrote. “For example, plasma discharge systems are not reliant on electrical spark gaps that erode pulse-by-pulse, which can introduce pulse-to-pulse variability. We observed low rates of myocardial capture, possibly because copper wires, unlike optical fibers, generate electromagnetic noise during arc discharge that may affect the cardiac conduction system. The 8-emitter configuration of the novel IVL catheter produces a uniform energy profile, which may increase the likelihood of fracturing both concentric and eccentric calcification.”
Much more research is still necessary, and a larger trial—FRACTURE—is already in the works.
For now, this technology is not approved by the FDA for treating coronary lesions. It is only available in the U.S. in an investigational capacity.
Click here to read the full study.
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.