FDA Clears Bolt Medical IVL System for ATK, Boston Scientific Closes Acquisition

April 3, 2025—Boston Scientific announced via social media that it has closed the acquisition of Bolt Medical, which recently gained FDA clearance of its intravascular lithotripsy (IVL) platform for the above-the-knee (ATK) indication. The FDA clearance letter for the Bolt IVL system, dated March 25, 2025, is available on the FDA website here.

In a communication with Endovascular Today, Boston Scientific stated that it is excited to have received 510(k) clearance of the Bolt IVL device for the ATK indication, and, with the acquisition now closed, the company looks forward to the launch of the device.

In January 2025, Boston Scientific announced a definitive acquisition agreement with Bolt valued at up to approximately $644 million in upfront cash and potential future milestone payments. The company stated that the Bolt Medical IVL system fractures arterial calcium using acoustic pressure waves delivered via a balloon catheter. The laser- and optics-based Bolt peripheral IVL system was developed for the treatment of both ATK and below-the-knee (BTK) calcified lesions.

Data supporting the use of the platform in lower extremity applications were established in the European RESTORE ATK and RESTORE BTK prospective, nonrandomized, multicenter studies. The findings from these studies were presented by Professor Thomas Zeller, MD, at VIVA24, the 22nd annual Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on November 3-6 in Las Vegas, Nevada.

In a previous press release, Boston Scientific noted that in December 2024, Bolt Medical received FDA approval to commence the global FRACTURE investigational device exemption clinical trial in the United States to evaluate the use of the Bolt IVL coronary system for the treatment of coronary artery disease with severely calcified lesions.

Boston Scientific also recently announced an agreement to acquire SoniVie Ltd., which has developed the investigational Tivus intravascular ultrasound system for renal denervation to treat hypertension.