Boston Scientific's SEISMIQ 4CE coronary intravascular lithotripsy catheter met its primary safety and effectiveness endpoints in the pivotal FRACTURE IDE trial, with results presented at EuroPCR 2026.
Boston Scientific has announced that its SEISMIQ™ 4CE Coronary Intravascular Lithotripsy (IVL) Catheter met the primary safety and effectiveness endpoints of the FRACTURE investigational device exemption (IDE) trial, a pivotal study designed to support U.S. regulatory clearance of the device for treating severely calcified coronary artery disease.
The prospective, single-arm trial enrolled 420 patients across 46 sites in the United States and Europe. It recorded a 93.3% rate of freedom from major adverse cardiac events at 30 days, well above the study's prespecified performance goal, along with a 93.7% procedural success rate. A sub-analysis also found favorable stent expansion in the most heavily calcified arterial segments, supporting the device's ability to prepare vessels for stent delivery.
The findings were presented at the EuroPCR 2026 congress in Paris and add to Boston Scientific's growing intravascular lithotripsy portfolio, which the company has been expanding as an alternative to atherectomy for treating calcified lesions ahead of stenting.
