Boston Scientific Advances Coronary Calcium Treatment With Positive Trial Results

Boston Scientific Corporation (NYSE:BSX) on Tuesday reported positive pivotal trial data for its investigational SEISMIQ 4CE Coronary Intravascular Lithotripsy catheter, with the device meeting both primary safety and effectiveness goals in patients with severely calcified coronary artery disease.

The study evaluated the use of the coronary intravascular lithotripsy (IVL) catheter in patients undergoing percutaneous coronary intervention procedures.

Trial Met Safety And Effectiveness Endpoints

The trial enrolled 420 patients with severe coronary artery disease.

The primary safety endpoint was achieved with a 93.3% rate of freedom from major adverse cardiac events at 30 days.

The endpoint included cardiovascular death, myocardial infarction, and target vessel revascularization, exceeding the pre-specified benchmark of 86.2%.

The trial also met its primary effectiveness endpoint, recording a 93.7% procedural success rate, surpassing the predefined goal of 85.8%.

The medical devices giant said stents were successfully delivered in all treated patients, with residual stenosis below 50%.

A sub-analysis showed an average stent expansion rate of 94.2% at the most calcified portion of the artery, which the company said supported favorable stent placement outcomes.

Device Designed To Treat Coronary Calcium

The SEISMIQ 4CE catheter uses laser-generated acoustic pressure waves delivered through a balloon catheter to fracture calcium buildup in coronary arteries. The technology is designed to improve vessel preparation before stent implantation and expansion.

The investigational coronary catheter is compatible with the same console used in the SEISMIQ IVL System for peripheral artery disease, which received FDA clearance in 2025.

Boston Scientific shares were up 2.27% at $57.19 at the time of publication on Tuesday, according to Benzinga Pro.

Price Action

Over the past month, BSX has declined about 9.4% while the S&P 500 has risen 3.4%, and is down roughly 40% year-to-date compared to the index’s 6.9% gain.

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