Late Breaking Clinical Trial from AVS IVL Pivotal Study to be Presented at VIVA

POWER PAD II IDE trial evaluates safety and efficacy of the Pulse IVL™ system in patients with severely calcified peripheral arterial disease

BOSTON--(BUSINESS WIRE)--Amplitude Vascular Systems (AVS), a medical device company focused on safely and effectively treating severely calcified arterial disease, announced today that it will present 30-day results of its POWER PAD II U.S. pivotal trial for Pulsatile Intravascular Lithotripsy (PIVL) therapy as a Late Breaking Clinical Trial (LBCT) at the Vascular InterVentional Advances (VIVA) meeting in November. The POWER PAD II clinical study was designed to evaluate the safety and efficacy of AVS’s Pulse IVL™ System for the treatment of patients with moderate to severely calcified peripheral arterial disease in the United States. Chris Metzger, M.D., Interventional Cardiologist at Ballad Health in Kingsport, Tenn., is the National Principal Investigator of the POWER PAD II Trial.

“AVS is the only company to conduct an Above-The-Knee (ATK) Intravascular Lithotripsy pivotal IDE study in the U.S., and we are excited to present our initial findings at the Late Breaking Clinical Trial session at VIVA,” said Elizabeth Galle, Vice President of Clinical Affairs at AVS. “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 innovative technology, which is designed for easy delivery across complex calcified lesions.”

“It has been a distinct pleasure overseeing this trial, in collaboration with our study investigators and more importantly, the patients who have benefited from this innovative approach to Intravascular Lithotripsy. I received feedback from several of our investigators that they appreciated the procedural efficiency due to its improved deliverability and fast therapeutic delivery,” said Dr. Metzger.

“By introducing a new, innovative treatment for calcified arterial disease, we can make a dramatic impact on patient lives and improve outcomes,” said Mark Toland, Chairman of AVS. “The results of this pivotal trial will pave the way for FDA 510k clearance and commercial availability of a new treatment option in an evolving and exciting area of medicine: 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 Boston, 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.