Late-breaking data from global pivotal study achieved high rates of freedom from major adverse cardiac events and procedural success in patients with severe coronary artery disease

MARLBOROUGH, Mass. and PARIS, May 19, 2026 /PRNewswire/ -- Boston Scientific Corporation (NYSE:BSX) today announced positive results from the pivotal FRACTURE Investigational Device Exemption (IDE) trial evaluating the use of the SEISMIQ™ 4CE Coronary Intravascular Lithotripsy Catheter* to treat patients with severely calcified coronary artery disease (CAD). The study met its primary safety and effectiveness endpoints, demonstrating high rates of freedom from major adverse cardiac events (MACE) at 30 days as well as procedural success. Findings from the trial were presented in a late-breaking trial session at the EuroPCR 2026 congress.

Moderate-to-severe coronary calcification – a hardened build-up of calcium that can narrow coronary arteries – is present in nearly one-third of patients undergoing percutaneous coronary intervention (PCI) to treat CAD, presenting a major challenge that can complicate stent delivery and expansion and increase the risk of procedural complications such as vessel dissection.1 The SEISMIQ 4CE catheter is an intravascular lithotripsy (IVL) device that uses laser energy within a balloon catheter to generate acoustic pressure waves that fracture calcium. The system's visible, directional emitters are designed to provide controlled, consistent energy delivery at low pressure to treat the calcium and prepare the vessel for stent implantation and maximum stent expansion to restore blood flow.