Boston Scientific Corporation announced on January 8, 2025, its definitive agreement to acquire Bolt Medical, Inc., the developer of an intravascular lithotripsy (IVL) laser-based platform for treating coronary and peripheral artery disease (PAD). The transaction is anticipated to conclude in the first half of 2025, pending standard closing conditions.
Boston Scientific, which initially conceptualized the Bolt IVL system and played a pivotal role in establishing Bolt Medical in 2019, currently holds an equity stake of approximately 26% in Bolt Medical. The acquisition deal includes an upfront payment of about $443 million for the remaining 74% stake, with the possibility of an additional $221 million upon achieving certain regulatory milestones.
The Bolt IVL system employs lithotripsy to break down calcium by generating acoustic pressure waves within a balloon catheter. It features visible, directional emitters for consistent energy delivery in treating calcified lesions. However, it's important to note that the Bolt IVL system is still an investigational device and has not been approved for commercial distribution in any country.
In November 2024, Bolt Medical revealed the completion and outcomes of the RESTORE ATK and RESTORE BTK pivotal clinical trials. These trials explored the efficacy of the Bolt IVL above-the-knee and below-the-knee systems in treating PAD in patients with moderately to severely calcified lesions. Conducted across Europe, these prospective, nonrandomized, multicenter studies' data will support FDA and CE Mark regulatory submissions for the devices. The results were presented by Thomas Zeller, MD, at VIVA24, the 22nd annual Vascular InterVentional Advances symposium organized by The VIVA Foundation from November 3-6 in Las Vegas, Nevada.
