Boston Scientific’s Seismiq 4CE Coronary IVL Catheter Studied in FRACTURE IDE Trial 

May 26, 2026—Boston Scientific Corporation announced results from the pivotal FRACTURE investigational device exemption (IDE) trial evaluating the use of the company’s Seismiq 4CE (pronounced “Force”) coronary intravascular lithotripsy (IVL) catheter to treat patients with severely calcified coronary artery disease (CAD).

The prospective, nonrandomized, single-arm trial enrolled 420 patients across 46 sites in the United States and Europe with patients followed for 2 years.

According to the company, 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 in Paris, France.

Boston Scientific reported that FRACTURE met all prespecified safety and effectiveness endpoints.

The press release outlined the key findings as follows:

• The primary safety endpoint was met with a 93.3% rate of freedom from MACE—including cardiovascular death, myocardial infarction, or target vessel revascularization—at 30 days, exceeding a prespecified performance goal of 86.2% (P < .0001).
• The primary effectiveness endpoint was met with a 93.7% rate of procedural success, defined as successful stent delivery with a final residual stenosis of < 50% and freedom from in-hospital MACE. This exceeded a prespecified performance goal of 85.8% (P < .0001). Treatment with the Seismiq 4CE device resulted in 100% successful stent delivery and final in-stent residual stenosis < 50%.
• A subanalysis of the data found a 94.2% average stent expansion rate at the most calcified segment of the artery, with favorable stent sizing that exceeded clinically significant thresholds, helping to create space within the vessel and support optimal stent placement.

The investigational Seismiq 4CE coronary IVL catheter is compatible with the same console used in the Seismiq IVL system with the Seismiq IVL peripheral catheter, which received FDA clearance in 2025 for the treatment of patients with severely calcified peripheral artery disease, advised Boston Scientific.