Amplitude Vascular Systems (AVS) announced today that it has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to begin its pivotal trial for pulsatile intravascular lithotripsy (IVL) 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 (PAD) in the USA.
POWER-PAD-II will enrol up to 120 patients 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 (Pennsylvania Hospital, Philadelphia, USA) at TCT 2023 (23–27 October, San Francisco, USA). 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 USA,” 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 (OhioHealth, Columbus, USA), national 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.”
