WALTHAM, Mass. — Amplitude Vascular Systems (AVS), a medical device company focused on treating severely calcified arterial disease, has reported positive results from the first 95 patients enrolled in the POWER PAD II U.S. pivotal study evaluating its Pulsatile Intravascular Lithotripsy (PIVL) therapy. The findings were presented as a Late Breaking Clinical Trial at the Vascular InterVentional Advances (VIVA) meeting in Las Vegas.
The prospective, single-arm study is designed to assess the safety and effectiveness of the Pulse IVL System in patients with moderate to severely calcified peripheral arterial disease. Dr. Chris Metzger, Interventional Cardiologist at Ballad Health in Kingsport, Tennessee, served as the principal investigator and presented the data.
The primary safety endpoint measured freedom from Major Adverse Events (MAEs) within 30 days of the procedure. MAEs included emergent surgical revascularization, unplanned target limb amputation, symptomatic thrombus or distal emboli, or severe dissection or perforation requiring urgent intervention. At 30 days, one MAE was reported, involving an unplanned major amputation. The primary effectiveness endpoint required achieving a final residual diameter stenosis of less than 50%. Of the 95 patients treated, 94 met this endpoint.
Successful treatment of these first 95 patients will support AVS’s planned FDA 510(k) submission for the Pulse IVL System, currently targeted for 2026.
“The POWER PAD II study has provided outstanding safety and efficacy data in 95 patients at 30 days. We are especially pleased with the results given the complexity of the patients treated, which included 100% severely calcified lesions according to the PARC 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,” said Dr. Metzger.
“AVS is the only company to conduct an Above-The-Knee Intravascular Lithotripsy pivotal IDE study in the U.S., and we were very pleased with the initial findings,” said Elizabeth Galle, Vice President of Clinical Affairs at AVS. “This marks our most significant clinical milestone to date as we approach potential FDA clearance for the Pulse IVL System. We are confident in our innovative technology, and these positive results reinforce our belief in the benefits of Pulse IVL for the treatment of significant calcific disease.”
“We are thrilled with the results of the POWER PAD II pivotal study and are grateful to all of the investigators, research and hospital staff, as well as the patients involved,” said Mark Toland, Chairman of the Board of AVS. “The results of this pivotal study will pave the way for our FDA 510(k) submission and the potential commercial availability of this unique approach to IVL therapy.”
