Bolt Medical announces its shockwave balloon on self-media platforms---Bolt IVLCompletedFRACTURE IDE Clinical Enrollment, from the First Case to Completion of All400 patients enrolled (Bolt Medical's efficiency is indeed very high).

FRACTUREResearch is aA prospective, non-randomized, single-arm, multi-center interventional study plans to enroll approximately 400 patients across 30 centers in the United States and Europe.This study aims to evaluateBolt IVLSafety and Performance of PCI Treatment in Patients with Severe Calcified Coronary Artery Lesions — This patient population has always been a significant challenge in clinical practice.

Executive Evaluation

“Completion of Patient Enrollment in the FRACTURE IDE Trial Marks an Important Milestone in the Field of Interventional Cardiology. The study aims to evaluateBolt IVLSafety and Efficacy in Treating Patients with Severe Calcified Coronary Artery Lesions Undergoing PCI Procedures — This patient population has always been a significant challenge in clinical practice. The successful completion of patient enrollment reflects our investigators, clinical research teams, and partners' steadfast commitment to advancing patient-centered, evidence-based innovation. I look forward to the scientific insights this trial will bring and extend my gratitude to all participants for their dedication to high-quality research."

---Janar Sathananthan, Boston ScientificChief Medical Officer

Bolt IVLIt was 664 million US dollars that Boston Scientific spent in the early last year.Advance PaymentAcquisitionBolt Medical shortly after the acquisition.Bolt IVLThe First Indication (Applicable toTreatment of stenotic lesions above the knee) has received FDA approval for marketing, breaking Johnson & Johnson's monopoly in the United States.

NowadaysBolt IVLCompleted clinical enrollment in the coronary field, and it will soon be launched in the United States. The competition between Boston Scientific and Johnson & Johnson in the shockwave balloon field is also entering uncharted waters.

Bolt IVL

Bolt IVLIt is an innovative shockwave balloon product designed to disrupt the intima and deep calcium by generating acoustic pressure waves within the balloon catheter. It features enhanced deliverability, a highly navigable catheter, and visible directional emitters, providing consistent energy for the treatment of concentric and eccentric cardiovascular calcified lesions.

Bolt IVLUnlike Shockwave IVL, which uses laser-based IVL technology. The laser energy is distributed through optical fibers to multiple positions within the balloon, and then through the balloon.The plasma generated internally is converted into a shock wave, thereby achievingEffect of Intravascular Lithotripsy.

Principle of Shock Waves in Laser Products

Bolt IVL In Vitro Demonstration