AVS Receives IDE for Pulse IVL System’s POWER PAD II Pivotal Trial

June 6, 2024—Amplitude Vascular Systems (AVS), which is focused on treating severely calcified arterial disease, announced that it has received an investigational device exemption from the FDA to begin its pivotal trial of its Pulse device for pulsatile intravascular lithotripsy (IVL) therapy.

In its press release, AVS advised that the POWER PAD II clinical study will evaluate the safety and efficacy of the Pulse IVL system for the treatment of patients with severely calcified peripheral arterial disease in the United States. The trial will enroll up to 120 patients who will be followed for up to 6 months. Chris Metzger, MD, is National Study Principal Investigator of POWER PAD II.

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

According to the company, the first-in-human POWER-PAD-I, demonstrated benefits to patients with calcific femoropopliteal arteries, including reduced leg pain, increased blood flow and improved ability to walk. The POWER PAD I findings were presented by Jon George, MD, at TCT 2023, the 35th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 23-26 in San Francisco, California. AVS announced the beginning of enrollment in POWER-PAD-I in September 2022.

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