What's Happening?
Boston Scientific Corporation announced successful results from the FRACTURE Investigational Device Exemption (IDE) trial for its SEISMIQ 4CE Coronary Intravascular Lithotripsy Catheter. The trial, which was presented at the EuroPCR 2026 congress, demonstrated
high rates of freedom from major adverse cardiac events and procedural success in patients with severe coronary artery disease. The SEISMIQ 4CE catheter uses laser energy to generate acoustic pressure waves that fracture calcium in coronary arteries, facilitating stent delivery and expansion. The trial enrolled 420 patients and met its primary safety and effectiveness endpoints, with a 93.3% rate of freedom from major adverse cardiac events and a 93.7% rate of procedural success.
Why It's Important?
The positive results from the FRACTURE trial are significant for the medical community as they provide evidence supporting the use of the SEISMIQ 4CE catheter in treating severely calcified coronary artery disease. This development could lead to broader adoption of intravascular lithotripsy (IVL) therapy, which addresses a critical level of coronary artery narrowing that poses risks of heart attack and other complications. The trial's success may influence regulatory submissions and approvals, potentially offering a new treatment option for high-risk patients and improving outcomes in complex percutaneous coronary intervention procedures.
What's Next?
Following the trial's success, Boston Scientific plans to use the data to support regulatory submissions for the SEISMIQ 4CE catheter. The company aims to provide physicians with a differentiated coronary IVL device option, potentially expanding treatment options for patients with severe coronary artery disease. The trial participants will continue to be monitored for two years to gather long-term data on the device's effectiveness and safety.
