Boston Scientific Coronary IVL Catheter Hits 93.3% Safety, 93.7% Effectiveness
BSX•Boston Scientific’s SEISMIQ 4CE Coronary IVL catheter achieved 93.3% freedom from major adverse cardiac events at 30 days versus an 86.2% goal in the 420-patient FRACTURE trial. Procedural success reached 93.7% for stent delivery with under 50% residual stenosis, surpassing the 85.8% target.
1. FRACTURE Trial Results
The 420-patient FRACTURE trial met its primary safety endpoint with 93.3% freedom from major adverse cardiac events at 30 days, exceeding the 86.2% performance goal. It also achieved a 93.7% procedural success rate for stent delivery with residual stenosis under 50%, above the 85.8% target.
2. Device Technology and Development
Seismiq 4CE uses laser-generated acoustic pressure waves to fracture calcified plaque and prepare arteries for stent placement. The catheter leverages the same console as the company’s peripheral IVL system acquired via the $664 million Bolt Medical deal, supporting streamlined adoption in interventional cardiology suites.
3. Market Context and Competition
Boston Scientific enters a growing coronary IVL market led by Shockwave Medical, acquired by J&J for $13.1 billion. Stryker’s recent acquisition of AVS and IDE approval for its Pulse IVL device signals increasing competition and validates the technology’s commercial potential.
