Amplitude Vascular Systems (AVS) has enrolled the first patient(s) in its U.S. pivotal trial for Pulsatile Intravascular Lithotripsy (PIVL) therapy.

The POWER PAD II clinical study will evaluate the safety and efficacy of the company’s Pulse IVL System for treating moderate to severely calcified peripheral arterial disease. Nicolas W. Shammas, M.D., conducted the first case at UnityPoint Trinity Medical Center in Bettendorf, Iowa.

“UnityPoint Trinity Medical Center is proud to enroll the first patient in the POWER PAD II Study and we are grateful for the opportunity to be the first hospital to treat a U.S. patient with this innovative approach to Intravascular Lithotripsy. 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,” said Dr. Shammas, who is also president and director of the Midwest Cardiovascular Research Foundation.

AVS received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) in June to begin POWER PAD II. The trial will enroll up to 120 subjects who will be followed for up to six months at up to 20 U.S. facilities.

“AVS is one of the first companies to conduct a peripheral intravascular lithotripsy pivotal IDE trial in the U.S., and this patient is the first of many U.S. patients who will benefit from our innovative technology,” AVS Vice President of Clinical Affairs Elizabeth Galle said. “This marks our most significant clinical milestone to date as we approach FDA clearance and market availability for the Pulse IVL System. We are confident in our technology, which is designed for easy delivery across complex calcified lesions and can reduce overall procedural costs.”

“By introducing a new, innovative treatment for calcified arterial disease, we can make a dramatic impact on patient lives and improve outcomes,” said Dr. Chris Metzger, POWER PAD II study national principal investigator. “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.”

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