Amplitude Vascular Systems (AVS), a medical device company specializing in treating severely calcified arterial disease with its Pulse Intravascular Lithotripsy (IVL) platform, has announced a strategic partnership with the Jacobs Institute, a nonprofit medical device innovation center in Buffalo, N.Y., led by Dr. Adnan Siddiqui. This collaboration will conduct clinical studies to evaluate the Pulse IVL™ System in both coronary and carotid vasculatures, with the goal of broadening the system’s clinical indications.
Pulse IVL™ is an Intravascular Lithotripsy device that uses high-frequency pressure waves to fracture calcium in arteries, combined with a non-compliant balloon to expand the vessel. The new partnership between Amplitude Vascular Systems (AVS) and the Jacobs Institute, a nonprofit medical device innovation center in Buffalo, N.Y., led by Dr. Adnan Siddiqui, aims to accelerate the development and market entry of the Pulse IVL™ System for coronary and carotid indications.
Mark Toland, Chairman of the Board of AVS, stated, “The Jacobs Institute and Dr. Siddiqui are exceptionally equipped to guide us through the regulatory approval process. Their infrastructure is designed to expedite the transition from development to clinical trials and commercialization. We are thrilled to collaborate with the JI to extend the Pulse IVL System’s applications to coronary and carotid lesions.”
Each year, around six million interventional procedures are performed for Coronary Artery Disease, with a significant portion involving calcific challenges. Carotid Artery Disease affects about 800,000 people in the U.S. annually and contributes to a third of all strokes, yet no IVL devices have received FDA approval for Carotid Artery Disease. The AVS-Jacobs Institute collaboration seeks to provide a new treatment option for stroke patients and potentially reduce stroke-related death and disability.
Dr. Siddiqui commented, “The Pulse IVL System aligns perfectly with the Jacobs Institute’s mission. Our innovation-driven environment will help bring this technology to patients more quickly, offering improved treatment options for coronary and carotid artery diseases. We are particularly excited about its potential in treating Carotid disease to enhance stroke care, given its unique mechanism of action.”
AVS has recently obtained FDA approval to initiate a U.S. IDE peripheral vascular clinical trial for Intravascular Lithotripsy. The POWER-PAD-II trial is set to begin enrollment soon at up to 20 U.S. centers.
For more information about AVS and the Pulse IVL™ System, visit: www.avspulse.com.
About AVS
Amplitude Vascular Systems (AVS), based in Boston, MA, focuses on safely and effectively treating severely calcified arterial disease. The company is supported by global investors such as BioStar Capital and Cue Growth Partners. Learn more about pulsatile intravascular lithotripsy at www.avspulse.com. The Pulse IVL™ System is investigational and not yet approved for commercial distribution.
About the Jacobs Institute
The Jacobs Institute is a non-profit dedicated to advancing next-generation technologies for vascular and neurologic diseases through collaboration among physicians, engineers, entrepreneurs, and industry. The institute aims to enhance treatment for vascular and neurologic conditions in Western New York and globally while supporting local economic development. Partnering with the University at Buffalo, Kaleida Health, and various industry players, the JI honors the legacy of Lawrence D. Jacobs, MD. The JI’s i2R (Idea to Reality Center) progresses vascular and neurologic medical device ideas through proof-of-concept, and the institute also enhances knowledge through clinical education programs.
