FRACTURE Trial of Boston Scientific’s Bolt IVL System Begins Enrollment in United States

July 3, 2025—Boston Scientific recently announced that it has commenced United States enrollment in the global FRACTURE investigational device exemption trial. The study will assess the safety and efficacy of the Bolt Medical intravascular lithotripsy (IVL) system in patients undergoing percutaneous coronary intervention for the treatment of coronary artery disease with severely calcified lesions.

Brian K. Jefferson, MD, from TriStar Centennial Medical Center in Nashville, Tennessee, and an investigator with the HCA Healthcare Research Institute, performed the first procedures in the trial in the United States, noted the company’s announcement via social media.

In January 2025, Boston Scientific announced its acquisition of Bolt Medical, which developed the laser-based IVL platform for the treatment of coronary and peripheral artery disease.

In the January announcement, the company advised that Bolt Medical had received FDA approval to commence the FRACTURE trial in the United States.

As noted in the FDA Clinical Trials Registry, the global FRACTURE trial is a prospective, nonrandomized, single-arm, multicenter, interventional study that will enroll an estimated 400 patients at 30 centers in the United States and Europe.

Bolt IVL system is an investigational device for this indication, limited by United States law to investigational use only and is not available for sale. In March 2025, the device received FDA clearance for an indication to treat above-the-knee peripheral artery disease.