AVS Receives IDE Approval from FDA for Pivotal Intravascular Lithotripsy Study

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 has received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin its pivotal trial for pulsatile intravascular lithotripsy (PIVL) therapy. The POWER-PAD-II clinical study will evaluate the safety and efficacy of AVS’s Pulse IVL™ System for the treatment of patients with severely calcified peripheral arterial disease in the United States.

“By introducing a new, innovative treatment for calcified arterial disease, we can make a dramatic impact on patient lives and improve outcomes”

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POWER-PAD-II will enroll up to 120 subjects who will be followed for up to six months. This new trial follows the success of POWER-PAD-I, which was presented by Jon George, MD, at TCT in October 2023. POWER-PAD-I demonstrated clear benefits to patients with calcific femoropopliteal arteries, including reduced leg pain, increased blood flow and improved ability to walk.

“We are proud to be one of the first companies to conduct a peripheral intravascular lithotripsy pivotal IDE trial in the US,” said Mark Toland, Chairman of the Board of AVS. “The IDE approval marks our most significant clinical milestone to date as we approach FDA clearance and market availability for the Pulse IVL™ System, which is designed to easily deliver therapy across complex calcified lesions and 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 Chris Metzger, M.D., National Study Principal Investigator of the POWER-PAD-II Study. “The results of our pivotal trial will pave the way for 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.