AVS Bags IDE NOD From FDA For Pivotal Intravascular Lithotripsy Study

Amplitude Vascular Systems (AVS), a medical device company focused on the safe and effective treatment of severely calcified arterial disease, declared that it has received an investigational device exemption (IDE) from the United States Food and Drug Administration (FDA) to begin its pivotal trial for pulsatile intravascular lithotripsy (PIVL). The POWER-PAD-II clinical research will assess the safety and efficacy of AVS's Pulse IVL™ System in treating patients with highly calcified peripheral artery disease in the US.

120 patients may be recruited for POWER-PAD-II, and they may be monitored for a maximum of six months. The success of POWER-PAD-I, which was introduced by Jon George, MD, at TCT in October 2023, is being followed up with this new experiment. Patients with calcific femoropopliteal arteries benefited clearly with POWER-PAD-I, as evidenced by enhanced walking ability, decreased leg pain, and increased blood flow.

"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."