Amplitude Vascular Systems (AVS) recently announced that it has enrolled the first patient in its U.S. pivotal trial for pulsatile intravascular lithotripsy (IVL) therapy.
A press release notes that the POWER PAD II clinical study will evaluate the safety and efficacy of AVS’s Pulse IVL system for the treatment of patients with moderate to severely calcified peripheral arterial disease (PAD). Nicolas W. Shammas, MD, an interventional cardiologist, conducted the first case at UnityPoint Trinity Medical Center in Bettendorf, Iowa.
AVS received an investigational device exemption (IDE) from the Food and Drug Administration (FDA) in June 2024 to begin POWER PAD II. The trial will enroll up to 120 patients who will be followed for up to six months at as many as 20 facilities.
“We found the device to be very deliverable and incredibly efficient at effectively modifying calcium and ultimately restoring blood flow to our patients’ vascular system,” said Shammas, who is also president and director of the Midwest Cardiovascular Research Foundation.
