The first US procedures have been performed in the FRACTURE investigational device exemption (IDE) trial of the Bolt intravascular lithotripsy (IVL) system in patients undergoing percutaneous coronary intervention (PCI) for the treatment of coronary artery disease in severely calcified lesions.
Brian K Jefferson, a physician at TriStar Centennial Medical Center (Nashville, USA) and investigator with the HCA Healthcare Research Institute, performed the first US procedures, officially initiating enrolment in the prospective, non-randomised, single-arm, multicentre trial at US sites.
In January, Boston Scientific entered into a definitive agreement to acquire Bolt Medical, having helped to initially develop the concept for the Bolt IVL system, which helped establish Bolt Medical in 2019.
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.
Bolt Medical has completed 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 US Food and Drug Administration (FDA) and CE mark regulatory submissions for the devices.
