Boston Scientific's SEISMIQ 4CE Catheter Meets Key Trial Endpoints in Severe Coronary Artery Disease
Event summary
- Boston Scientific's SEISMIQ 4CE Coronary Intravascular Lithotripsy Catheter met primary safety and effectiveness endpoints in the FRACTURE IDE trial.
- The trial achieved a 93.3% rate of freedom from major adverse cardiac events (MACE) at 30 days, exceeding the prespecified performance goal of 86.2%.
- Procedural success rate was 93.7%, with 100% successful stent delivery and final in-stent residual stenosis less than 50%.
- The trial enrolled 420 patients across 46 sites in the U.S. and Europe, with findings presented at EuroPCR 2026.
The big picture
The successful trial results position Boston Scientific to potentially expand its offerings in the rapidly growing intravascular lithotripsy therapy segment. The SEISMIQ 4CE catheter aims to address a critical challenge in treating severely calcified coronary artery disease, which affects nearly one-third of patients undergoing percutaneous coronary intervention. The data supports Boston Scientific's strategy to provide innovative solutions for complex PCI procedures, potentially improving outcomes for high-risk patients.
What we're watching
- Regulatory Approval
- Whether the positive trial results will expedite the regulatory submission and approval process for the SEISMIQ 4CE catheter.
- Market Adoption
- The pace at which the SEISMIQ 4CE catheter will be adopted by physicians for treating severely calcified coronary artery disease.
- Competitive Positioning
- How Boston Scientific will differentiate the SEISMIQ 4CE catheter in the growing intravascular lithotripsy therapy market.
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