FRACTURE IDE trial of the Boston Scientific SEISMIQ™ 4CE Coronary Intravascular Lithotripsy Catheter meets primary safety and effectiveness endpoints

Boston Scientific reported that the FRACTURE Investigational Device Exemption trial successfully met its primary safety and effectiveness endpoints for the SEISMIQ™ 4CE Coronary Intravascular Lithotripsy Catheter. The study demonstrated high rates of freedom from major adverse cardiac events at 30 days and procedural success in patients with severe coronary artery disease. Findings were presented at the EuroPCR 2026 congress in a late-breaking trial session. The trial enrolled 420 patients across 46 sites in the United States and Europe, with follow-up planned for two years.

The SEISMIQ 4CE catheter uses intravascular lithotripsy to fracture calcium deposits in coronary arteries, addressing a major challenge in percutaneous coronary intervention procedures. Moderate-to-severe calcification, present in nearly one-third of patients, complicates stent delivery and increases procedural risks. The device employs laser-generated acoustic pressure waves within a balloon catheter to prepare vessels for stent implantation and improve blood flow restoration.

Dr. Margaret McEntegart, co-principal investigator of the FRACTURE trial and director of Complex PCI and CTO Programs at Columbia University Irving Medical Center, highlighted the trial's reassuring safety data. She noted that stents were successfully delivered in all patients, no deaths occurred, and only one patient required target vessel revascularization at 30 days. The trial's outcomes support the potential expansion of coronary intravascular lithotripsy treatment options for severely diseased lesions.

Boston Scientific stated that the trial data will support its regulatory submission for the SEISMIQ 4CE catheter, which may offer physicians a new option for lesion preparation in complex PCI procedures. The investigational device is compatible with the same console used for the SEISMIQ IVL System, which received FDA clearance in 2025 for treating severely calcified peripheral artery disease. The company emphasized the growing adoption of intravascular lithotripsy therapy in addressing critical coronary artery narrowing.