Boston Scientific Corporation (NYSE: BSX) announced that its FRACTURE trial for the investigational SEISMIQ 4CE Coronary Intravascular Lithotripsy Catheter met primary safety and effectiveness endpoints. The results were presented at the EuroPCR 2026 congress.

The prospective, single-arm trial enrolled 420 patients with severe coronary artery disease across 46 sites in the United States and Europe. The study achieved a 93.3% rate of freedom from major adverse cardiac events at 30 days, exceeding the prespecified performance goal of 86.2%. The primary effectiveness endpoint showed a 93.7% rate of procedural success, surpassing the 85.8% performance goal.

The SEISMIQ 4CE catheter uses laser energy within a balloon catheter to generate acoustic pressure waves that fracture calcium deposits in coronary arteries. The device achieved 100% successful stent delivery in all treated patients, with final in-stent residual stenosis less than 50%.

"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," said Dr. Margaret McEntegart, co-principal investigator and director of Complex PCI and CTO Programs at Columbia University Irving Medical Center.

Moderate-to-severe coronary calcification affects nearly one-third of patients undergoing percutaneous coronary intervention. The condition can complicate stent delivery and increase procedural complications.

The investigational device is compatible with the same console used in Boston Scientific's SEISMIQ IVL System with the SEISMIQ IVL Peripheral Catheter, which received FDA clearance in 2025. The company plans to use the trial data for its regulatory submission for the coronary device.

Trial participants will be followed for two years after their procedures. The information is based on a company press release.