Boston Scientific finalizes Bolt Medical acquisition as FDA clears company’s IVL technology
Boston Scientific has finalized its acquisition of Bolt Medical, a California-based medical device company that specializes in intravascular lithotripsy (IVL) technology, just after the U.S. Food and Drug Administration (FDA) cleared Bolt Medical’s IVL system to be marketed and sold throughout the United States.
Boston Scientific did not share the news in an official press release. It did, however, issue an update on the Bolt Medical acquisition on social media.
“We look forward to advancing IVL therapy developed by Bolt, which will complement our cardiovascular portfolio by expanding treatment options for coronary and peripheral disease,” Boston Scientific said on its LinkedIn page.
Boston Scientific first announced its intention to purchase Bolt Medical for up to $664 million back in January. The company was a strategic investor in Bolt Medical from the jump and already owned an equity stake of approximately 26%.
“Representing one of the fastest growing medical device segments, IVL therapy addresses a significant unmet need for patients with complex calcified arterial disease through a minimally invasive approach,” Lance Bates, senior vice president and president of interventional cardiology therapies with Boston Scientific, said at the time. “Bolt Medical is developing a next-generation technology that is highly complementary to our existing portfolio. The addition of this system to our offerings can help us better serve physicians and their patients and provides a platform for future innovation.”
FDA clears Bolt Medical IVL system
The other significant piece of news related to Boston Scientific and Bolt Medical is the fact that the FDA has officially cleared the Bolt IVL System based on data from the RESTORE ATK clinical trial. Additional information is available in the FDA’s 510(k) database.
Again, Boston Scientific did not announce this FDA clearance with a press release, but the company did confirm the news through email.
“We are excited to have received 510(k) clearance from the FDA for the above-the-knee device, marking an important milestone in bringing this innovative technology to our customers and their patients,” a spokesperson told Cardiovascular Business. “Our commercial team is working diligently on plans to bring this device to market with an expected launch in the first half of 2026.”
Intravascular lithotripsy keeps gaining momentum
IVL, a process that involves breaking up heavily calcified plaques to prep a patient’s blood vessels for further treatment, is one of most in-demand technologies in all of healthcare. Johnson & Johnson acquired Shockwave Medical, the company that first started developing IVL in 2009, for $13 billion back in 2024. Several other major vendors, including Boston Scientific, were rumored to be interested in acquiring Shockwave Medical at the time.
Abbott made an IVL move of its own in March, receiving an investigational device exemption from the FDA to evaluate the safety and effectiveness of its coronary IVL technology.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.