New Era For Lithotripsy: AVS and Jacobs Institute Collaborate On Pioneering Trials

Amplitude Vascular Systems (AVS) has teamed up with the Jacobs Institute in New York, led by Dr. Adnan Siddiqui, to conduct clinical trials for the Pulse intravascular lithotripsy (IVL) system. Jacobs Institute, a nonprofit center dedicated to medical device innovation, will collaborate on evaluating the Pulse IVL system's effectiveness in treating both coronary and carotid arteries, with the goal of broadening its clinical applications. The Pulse IVL system works by employing high-frequency pressure waves to break down calcium deposits in arterial walls, using a non-compliant balloon to assist in expanding the vessels.

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.” He further added, “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.”

The collaboration aims to capitalize on the Jacobs Institute's expertise in clinical trials and regulatory processes to expedite the introduction of the Pulse IVL System for use in coronary and carotid treatments. In June 2024, the US Food and Drug Administration (FDA) approved an investigational device exemption (IDE) for a major trial assessing AVS's pulsatile intravascular lithotripsy therapy.

The POWER-PAD-II study will investigate how safe and effective AVS's Pulse IVL system is for treating patients with severely calcified peripheral arterial disease. Enrollment for the trial is expected to start soon at up to 20 locations across the US, with participants monitored for up to six months post-treatment.

AVS board chairman Mark Toland said in a statement, “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 commercialisation. We are excited to partner with the JI on expanding the use of the Pulse IVL system in coronary and carotid lesions.”