Key Takeaways:
Boston Scientific Corp.’s new catheter to break up calcium in clogged arteries succeeded in a pivotal 420-patient study, setting the stage for a regulatory submission that could challenge the market leader in the fast-growing field of intravascular lithotripsy.
“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,” said Dr. Margaret McEntegart, a co-principal investigator of the trial and a director at Columbia University Irving Medical Center.
The FRACTURE trial met both of its primary goals. The device achieved a 93.7 percent procedural success rate, defined as successful stent delivery with minimal blockage and no major in-hospital complications, exceeding its pre-specified goal of 85.8 percent. For safety, 93.3 percent of patients were free from major adverse cardiac events at 30 days, beating the target of 86.2 percent.
The positive results position Boston Scientific to compete more directly with Johnson & Johnson, which acquired intravascular lithotripsy (IVL) pioneer Shockwave Medical for $13.1 billion in April. The SEISMIQ 4CE system is designed to help physicians implant stents in patients with severely calcified coronary artery disease, a condition affecting nearly a third of individuals undergoing artery-opening procedures.
The SEISMIQ 4CE catheter uses laser energy to generate acoustic pressure waves, a method known as intravascular lithotripsy, to fracture hardened calcium deposits inside coronary arteries. This process prepares the vessel for a stent, and the trial demonstrated its effectiveness with a 100 percent stent delivery rate and an average stent expansion of 94.2 percent at the most calcified lesion segment.
The study, which was conducted across 46 sites in the U.S. and Europe, will follow patients for two years. The data presented at the EuroPCR 2026 congress is intended to support a regulatory submission for the device, which is currently for investigational use only.
For investors, the successful trial is a key step for Boston Scientific to capture share in the rapidly expanding IVL market. The company’s ability to offer a competitive alternative to Johnson & Johnson’s established Shockwave platform could open a significant new revenue stream and strengthen its position in interventional cardiology. The device uses the same console as Boston Scientific's peripheral IVL system, which received FDA clearance in 2025, potentially smoothing hospital adoption.
This article is for informational purposes only and does not constitute investment advice.
