AVS Partners With Jacobs Institute to Expedite Trials for Coronary and Carotid Indications of Pulse IVL System

August 20, 2024—Amplitude Vascular Systems (AVS), which is focused on the treatment of severely calcified arterial disease with its Pulse platform, announced it has entered into a strategic agreement with the Jacobs Institute, a nonprofit medical device innovation center in Buffalo, New York, led by Adnan Siddiqui, MD.

The partnership will execute clinical studies evaluating AVS’s Pulse intravascular lithotripsy (IVL) system in both coronary and carotid vasculatures and will aim to expand clinical indications for the device.

According to AVS, the Pulse IVL uses high-frequency pressure waves to fracture calcium with a noncompliant balloon to expand the vessel. It is an investigational device and not yet cleared for commercial distribution within or outside the United States.

The company advised that the clinical and regulatory capabilities of the Jacobs Institute will combine with the AVS lithotripsy technology to potentially expedite the time to market for coronary and carotid indications of the Pulse IVL system.

“We believe the Pulse IVL system is the perfect fit for the structure we’ve built at the Jacobs Institute,” commented Dr. Siddiqui in the AVS press release. “By fostering an environment that nurtures innovation, the Jacobs Institute will help to bring this technology to patients sooner, ultimately providing better treatment options for patients with coronary and carotid artery diseases.”

Dr. Siddiqui 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.”

In June 2024, AVS announced it received approval from the FDA to start a United States investigational device exemption peripheral vascular clinical trial for IVL. The POWER-PAD-II trial is expected to start enrollment in the coming weeks at up to 20 United States centers, advised the company.