Company’s agreement with the JI demonstrates progress toward commercialization of Pulse IVL™ Intravascular Lithotripsy System
August 20, 2024 07:58 AM Eastern Daylight Time
BOSTON–(BUSINESS WIRE)–Amplitude Vascular Systems (AVS), a medical device company focused on safely and effectively treating severely calcified arterial disease with its Pulse Intravascular Lithotripsy platform, today announced it has entered into a strategic agreement with the Jacobs Institute, a nonprofit medical device innovation center in Buffalo, N.Y., led by Adnan Siddiqui, M.D. The partnership will execute clinical studies evaluating the Pulse IVL™ System in both Coronary and Carotid vasculatures and aims to expand clinical indications for the Pulse IVL System.
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 coronary and carotid indications of the Pulse IVL System.
“The Jacobs Institute and Dr. Siddiqui are well positioned to assist companies in the regulatory approval journey,” said Mark Toland, Chairman of the Board of AVS. “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.”
There are approximately six million interventional procedures done each year 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 U.S. every year and causes up to one-third of all strokes, but no IVL devices have received FDA approval for treating Carotid Artery 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,” said Dr. Siddiqui. “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 start enrollment in the coming weeks at up to 20 U.S. centers.
To learn more about AVS and the PULSE IVL™ System, please visit: www.avspulse.com.
About AVS
Amplitude Vascular Systems (AVS) is a medical device company based in Boston, MA, focused on safely and effectively treating severely calcified arterial disease. AVS is backed by global investors including BioStar Capital, Cue Growth Partners, and others. To learn more about pulsatile intravascular lithotripsy, visit www.avspulse.com. The Pulse IVL™ System is an investigational device and not yet cleared for commercial distribution within or outside the United States.
About the Jacobs Institute
The Jacobs Institute is a non-profit organization whose mission is to accelerate the development of next-generation technologies for vascular and neurologic diseases through collisions of physicians, engineers, entrepreneurs, and industry. The JI’s vision is to improve the treatment of vascular and neurologic disease in Western New York and the world, while fostering local economic development. The JI fosters medical collaboration and innovation through partnerships with the University at Buffalo (UB), Kaleida Health, and industry to be a fitting tribute to the work and memory of Lawrence D. Jacobs, MD. 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.
