POWER PAD II Data Presented for AVS Pulse IVL System

November 4, 2025—Amplitude Vascular Systems (AVS) announced results from the first 95 patients treated in the POWER PAD II United States pivotal study for pulsatile intravascular lithotripsy (IVL) therapy. The prospective, single-arm study is designed to assess the safety and efficacy of AVS’s Pulse IVL system for the treatment of patients with moderate to severely calcified peripheral artery disease.

Principal Investigator Chris Metzger, MD, presented the study findings in a late-breaking clinical trial session at VIVA25.

According to the company, the primary safety endpoint of the study was freedom from major adverse events (MAEs) within 30 days after the index procedure. MAEs were defined as emergent surgical revascularization, unplanned target limb amputation, symptomatic thrombus or distal emboli, or severe dissection or perforation requiring urgent intervention.

The primary effectiveness endpoint was defined as final residual diameter stenosis < 50%.

As summarized in the AVS press release, through 30 days, there was one reported MAE (unplanned target limb major amputation) and 94 of 95 patients had a final residual stenosis < 50%.

Successful treatment of the first 95 patients in the POWER PAD II study will support 510(k) regulatory submission for the Pulse IVL system, noted the company.

“The POWER PAD II study has provided outstanding safety and efficacy data in 95 patients at 30 days,” commented Dr. Metzger in the AVS press release. “We are especially pleased with the results given the complexity of the patients treated, which included 100% severely calcified lesions according to the PARC [Peripheral Academic Research Consortium] definition. The efficient treatment effect provided by the unique mechanism of action of the Pulse IVL system has shown clear benefit to these difficult-to-treat patients.”