Amplitude Vascular Systems (AVS) announced today that it has received an investigational device exemption (IDE) from the 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 U.S.
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) at TCT 2023 (Oct. 23–27) in San Francisco. POWER-PAD-I demonstrated clear benefits to patients with calcific femoropopliteal arteries, including reduced leg pain, increased blood flow and improved ability to walk.
