Amplitude Vascular Systems (AVS) has announced the enrollment of the first patient in its U.S. pivotal trial, POWER PAD II, which will assess the safety and efficacy of the Pulse IVL™ system for treating moderate to severely calcified peripheral arterial disease. The first procedure was performed by Nicolas W. Shammas, MD, at UnityPoint Trinity Medical Center in Bettendorf, Iowa.
POWER PAD II Trial Details
The POWER PAD II clinical study is an IDE trial authorized by the U.S. Food and Drug Administration (FDA) in June 2024. It plans to enroll up to 120 subjects across approximately 20 U.S. centers. Participants will be followed for up to six months to evaluate the outcomes of the Pulse IVL™ System.
Elizabeth Galle, Vice President of Clinical Affairs at AVS, stated, "AVS is one of the first companies to conduct a peripheral intravascular lithotripsy pivotal IDE trial in the U.S... We are confident in our innovative technology, which is designed for easy delivery across complex calcified lesions and can reduce overall procedural costs."
Physician Perspectives
Dr. Shammas noted the efficiency of the device in modifying calcium and restoring blood flow, stating, "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. Chris Metzger, National Principal Investigator of the POWER PAD II Study, added, "The results of this U.S. pivotal trial will pave the way for a new treatment option in an evolving and exciting area of medicine: IVL therapy."
About the Pulse IVL System
The Pulse IVL™ System is designed to treat severely calcified arterial disease using pulsatile intravascular lithotripsy. AVS aims to secure FDA clearance and market availability for this system, which is currently under investigation and not yet cleared for commercial distribution.
