Summary: Boston Scientific will acquire Bolt Medical, developer of an intravascular lithotripsy (IVL) platform for calcified coronary and peripheral artery disease. Bolt’s system uses acoustic pressure waves to break up arterial calcium. The deal, worth up to $664 million, includes major clinical trials aimed at FDA and CE Mark approvals for multiple indications.

Key Takeaways:

  • Bolt Medical’s novel IVL platform complements Boston Scientific’s existing cardiovascular portfolio, targeting a fast-growing minimally invasive technology segment.
  • Ongoing pivotal trials for above/below-the-knee and coronary applications underscore the system’s potential to address complex calcified lesions across various vascular territories.

Boston Scientific Corporation has entered into a definitive agreement to acquire Bolt Medical, the developer of an intravascular lithotripsy (IVL) advanced laser-based platform for the treatment of coronary and peripheral artery disease.

Boston Scientific expects the transaction to be completed in the first half of 2025, subject to customary closing conditions.

“Representing one of the fastest growing medical device segments, intravascular lithotripsy therapy addresses a significant unmet need for patients with complex calcified arterial disease through a minimally invasive approach,” said Lance Bates, senior vice president and president, interventional cardiology therapies, Boston Scientific. “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.”

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About the Bolt IVL System

Lithotripsy is a procedure in which a physician breaks up hardened masses such as calcium to help restore blood flow. The Bolt IVL system is designed with a novel application of lithotripsy to fracture calcium by creating acoustic pressure waves inside of a balloon catheter. The system also includes visible, directional emitters for consistent energy delivery in the treatment of the calcified lesions.

Boston Scientific initially developed the concept for the Bolt IVL system which helped establish Bolt Medical in 2019. As a strategic investor in Bolt Medical, Boston Scientific has an equity stake of approximately 26%. As a result, the transaction consists of an upfront payment of approximately $443 million for the 74% stake not yet owned and up to $221 million upon achievement of certain regulatory milestones.

Clinical Trials and Regulatory Pathway

Bolt Medical recently announced the completion and results of the RESTORE ATK and RESTORE BTK pivotal clinical trials investigating the Bolt IVL Above the Knee (ATK) and Below the Knee (BTK) systems for the treatment of peripheral artery disease in patients with moderate to severely calcified lesions. The data from both studies will be used to support U.S. Food and Drug Administration (FDA) and CE Mark regulatory submissions for the devices. In December 2024, Bolt Medical received FDA approval to commence the global FRACTURE IDE clinical trial in the U.S., which is investigating the use of the Bolt IVL Coronary System for the treatment of coronary arterial disease with severely calcified lesions.