Boston Scientific's SEISMIQ 4CE Catheter Trial Posts 93.3% Safety, 93.7% Success
Boston Scientific enrolled 420 patients in the FRACTURE IDE trial of its SEISMIQ 4CE Coronary IVL Catheter and achieved a 93.3% freedom from major adverse cardiac events at 30 days, exceeding the 86.2% goal. The study posted a 93.7% procedural success rate with 100% stent delivery and 94.2% stent expansion.
1. Trial Design and Enrollment
The FRACTURE IDE trial was a prospective, non-randomized, single-arm study that enrolled 420 patients with severely calcified coronary artery disease across 46 sites in the U.S. and Europe. It evaluated the safety and effectiveness of the SEISMIQ 4CE Coronary Intravascular Lithotripsy Catheter during lesion preparation for percutaneous coronary intervention.
2. Safety Outcomes
The study met its primary safety endpoint with a 93.3% rate of freedom from major adverse cardiac events at 30 days, surpassing the prespecified goal of 86.2% (p<0.0001). No deaths occurred and only one patient required target vessel revascularization within the 30-day follow-up period.
3. Effectiveness Outcomes
Procedural success reached 93.7%, exceeding the 85.8% performance goal (p<0.0001), defined by successful stent delivery with residual stenosis below 50% and freedom from in-hospital MACE. All patients achieved stent delivery and a sub-analysis showed a 94.2% average stent expansion in the most calcified segments.
4. Next Steps and Implications
Patients will be followed for two years post-procedure to assess long-term safety and efficacy. Positive results support an upcoming regulatory submission for coronary IVL indication and may broaden adoption of the SEISMIQ 4CE system in complex PCI procedures.