AVS Announces Positive Safety and Effectiveness Data in First 95 Patients Treated in Pulse IVL IDE Study

Data from the POWER PAD II Study presented at VIVA will support FDA 510(k) submission in 2026

WALTHAM, Mass.--(BUSINESS WIRE)--Amplitude Vascular Systems (AVS), a medical device company focused on safely and effectively treating severely calcified arterial disease, presented the results of the first 95 patients treated in the POWER PAD II U.S. pivotal study for Pulsatile Intravascular Lithotripsy (PIVL) therapy as a Late Breaking Clinical Trial (LBCT) at the Vascular InterVentional Advances (VIVA) meeting in Las Vegas, NV. Principal Investigator, Dr. Chris Metzger, Interventional Cardiologist at Ballad Health in Kingsport, TN, presented the results from the prospective, single-arm study designed to assess the safety and efficacy of AVS’s Pulse IVL™ System for the treatment of patients with moderate to severely calcified peripheral arterial disease.

The primary safety endpoint of the study was freedom from Major Adverse Events (MAEs) within 30 days following 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%. Through 30 days, there was one reported MAE (unplanned target limb major amputation) and 94 of 95 subjects had a final residual stenosis <50%. Successful treatment of the first 95 patients in the POWER PAD II study will support the 510(k) regulatory submission for the Pulse IVL System.

“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 (ATK) 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.”

To learn more about AVS and the PULSE IVL™ System, please visit: www.avspulse.com

About AVS

Amplitude Vascular Systems (AVS) is a medical device company based in Waltham, MA, focused on safely and effectively treating severely calcified arterial disease. AVS is backed by global investors including BioStar Capital, Cue Growth Partners, and others. To learn more about pulsatile intravascular lithotripsy, visit www.avspulse.com.The Pulse Peripheral Intravascular Lithotripsy (IVL) System is an investigational device and not yet cleared for commercial distribution within or outside the United States.