EuroPCR 2026 — Professor Nicolas Van Mieghem joins us to discuss the FRACTURE trial, which evaluated the safety and effectiveness of the laser-based Seismic intravascular lithotripsy (IVL) system for the treatment of severely calcified coronary lesions.

The FRACTURE trial was designed to support both FDA IDE and CE mark regulatory approval. It prospectively enrolled 440 patients, with a primary safety endpoint of major adverse cardiac events (MACE) at 30 days, and an effectiveness endpoint of stent expansion with residual stenosis below 50% in the absence of MACE at hospital discharge. The study assessed the Seismic laser-based IVL system, developed by Bolt Medical and since acquired by Boston Scientific.

Findings showed that both the primary safety and effectiveness endpoints were met, with results exceeding the prespecified performance goals derived from earlier studies in calcific coronary disease.

Interview Questions:

1. What is the current unmet need in treating severely calcified coronary lesions, and where does intravascular lithotripsy fit within the existing toolkit?
2. What were the design rationale and primary objectives of the FRACTURE trial?
3. What were the headline findings?
4. How did the Bolt laser-based IVL system perform relative to existing calcium modification technologies?
5. What are the clinical implications of these findings for operators managing complex calcified lesions in everyday PCI practice?
6. What are the next steps for the FRACTURE programme, and what longer-term follow-up data are anticipated?

Recorded on-site at EuroPCR 2026, Paris.
Editors: Jordan Rance
Videographer: Dan Brent
Support: This is an independent interview produced by Radcliffe Cardiology.