AVS’s Pulse IVL POWER PAD II Pivotal Trial Begins Enrollment

October 15, 2024—Amplitude Vascular Systems (AVS), which is focused on treating severely calcified arterial disease, announced commencement of patient enrollment in the POWER PAD II United States pivotal trial of the company’s Pulse intravascular lithotripsy (IVL) system for pulsatile intravascular lithotripsy therapy.

According to the company, POWER PAD II will evaluate the safety and efficacy of the Pulse IVL system for treatment of patients with moderate to severely calcified peripheral arterial disease. Chris Metzger, MD, is national principal investigator of the POWER PAD II study.

Nicolas W. Shammas, MD, conducted the first case in the trial at UnityPoint Trinity Medical Center in Bettendorf, Iowa. Dr. Shammas is President and Director of the Midwest Cardiovascular Research Foundation.

“UnityPoint Trinity Medical Center is proud to enroll the first patient in the POWER PAD II study and we are grateful for the opportunity to be the first hospital to treat a United States patient with this innovative approach to IVL,” commented Dr. Shammas in the company’s press release. “We found the device to be very deliverable and incredibly efficient at effectively modifying calcium and ultimately restoring blood flow to our patients’ vascular system.”

Dr. Metzger added, “By introducing a new, innovative treatment for calcified arterial disease, we can make a dramatic impact on patient lives and improve outcomes. The results of this United States pivotal trial will pave the way for a new treatment option in an evolving and exciting area of medicine: IVL therapy.”

In June, AVS announced it received an investigational device exemption from the FDA to begin POWER PAD II. The trial will enroll up to 120 patients at up to 20 facilities in the United States. The patients will be followed for up to 6 months.

The Pulse IVL system is an investigational device and not yet cleared for commercial distribution within or outside the United States, advised AVS in the press release.