Amplitude Vascular Systems (AVS) is partnering with the Jacobs Institute to help improve stroke treatment.

The pair aims to initiate clinical studies that evaluate the Pulse Intravascular Lithotripsy (IVL) platform in both coronary and carotid vasculatures, and expand clinical indications for the Pulse IVL System. “The Jacobs Institute and Dr. Siddiqui are well positioned to assist companies in the regulatory approval journey,” AVS Board Chairman Mark Toland said. “Dr. Siddiqui and the team at the JI are committed to bringing novel technologies to market through their vertically aligned infrastructure which accelerates the pathway from development to clinical trials to commercialization. We are excited to partner with the JI on expanding the use of the Pulse IVL System in coronary and carotid lesions.”
 
Pulse IVL is an intravascular lithotripsy device that uses high-frequency pressure waves to fracture calcium with a non-compliant balloon to expand the vessel. This partnership combines the clinical and regulatory capabilities of the Jacobs Institute with the novel lithotripsy technology from AVS to potentially expedite the time to market for the Pulse IVL System’s coronary and carotid indications.
 
Approximately 6 million interventional procedures are conducted annually for patients with coronary artery disease, and conservatively, one-third of them present with calcific challenges. Carotid artery disease impacts about 800,000 people in the United States every year and causes up to one-third of all strokes, but no IVL devices have received U.S. Food and Drug Administration (FDA) approval for treating the disease. The joint effort between AVS and the Jacobs Institute will strive to create a new treatment option for stroke patients and potentially lighten the burden of death and disability caused by stroke.
 
“We believe the Pulse IVL System is the perfect fit for the structure we’ve built at the Jacobs Institute,” Jacobs Institute CEO/Chief Medical Officer Dr. Adnan H. Siddiqui stated. “By fostering an environment that nurtures innovation, the JI will help to bring this technology to patients sooner, ultimately providing better treatment options for patients with coronary and carotid artery diseases. We are especially excited about studying the Pulse IVL system in carotids to improve stroke care. We believe its unique mechanism of action may be an important solution for the diffuse and eccentric nature of many of our carotid disease patients.”
 
AVS recently received approval from the FDA to start a U.S. IDE peripheral vascular clinical trial for Intravascular Lithotripsy. The POWER-PAD-II trial is expected to enroll patients at up to 20 U.S. centers.
 
Amplitude Vascular Systems (AVS) is a medical device company based in Boston, that is focused on safely and effectively treating severely calcified arterial disease. AVS is backed by global investors including BioStar Capital, Cue Growth Partners, and others. The Pulse IVL System is an investigational device and not yet cleared for commercial distribution within or outside the United States.
 
The Jacobs Institute is a Buffalo, N.Y.-based non-profit organization accelerating the development of next-generation technologies for vascular and neurologic diseases through alliances with physicians, engineers, entrepreneurs, and industry. The JI fosters medical collaboration and innovation through partnerships with the University at Buffalo (UB), Kaleida Health, and industry. Additionally, the JI’s i2R, or Idea to Reality Center, is taking ideas for vascular and neurologic medical devices and moving them through the proof-of-concept process. Finally, the JI also increases physician and industry knowledge of vascular and neurologic diseases through clinical education programs.