Amplitude Vascular Systems (AVS) has received investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin a pivotal trial for pulsatile intravascular lithotripsy (PIVL) therapy.
 
The company’s Pulse IVL system uses low intensity, high frequency pressure waves to generate fractures in the plaque and expand stenotic lesions to restore blood flow. Waves are delivered to calcified vessels through a balloon that simultaneously fragments calcium and dilates the artery in the same treatment session.
 
The POWER-PAD-II study will evaluate AVS’ Pulse IVL to treat patients with severely calcified peripheral arterial disease (PAD) in the U.S. It will enroll up to 120 participants and follow them up to six months.
 
This trial comes after the success of POWER-PAD-I, which the company said showed clear benefits for patients with calcific femoropopliteal arteries. This included less leg pain, increased blood flow, and the improved ability to walk.
 
“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, MD, 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.”
 
“We are proud to be one of the first companies to conduct a peripheral intravascular lithotripsy pivotal IDE trial in the U.S.,” added 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.”