Amplitude Vascular Systems (AVS) recently announced that it has enrolled the first patient in its US 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 conducted the first case at UnityPoint Trinity Medical Center in Bettendorf, USA.
AVS received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) in June 2024 to begin POWER PAD II. The trial will enrol up to 120 patients who will be followed for up to six months at up to 20 US facilities.
“AVS is one of the first companies to conduct a peripheral intravascular lithotripsy pivotal IDE trial in the USA, and this patient is the first of many US patients who will benefit from our innovative technology,” said Elizabeth Galle, vice president of clinical affairs at AVS. “This marks our most significant clinical milestone to date as we approach FDA clearance and market availability for the Pulse IVL system. We are confident in our innovative technology, which is designed for easy delivery across complex calcified lesions and can reduce overall procedural costs.”
“UnityPoint Trinity Medical Center is proud to enrol the first patient in the POWER PAD II study and we are grateful for the opportunity to be the first hospital to treat a US patient with this innovative approach to intravascular lithotripsy. 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.
“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, national principal investigator of the POWER PAD II study. “The results of this US pivotal trial will pave the way for a new treatment option in an evolving and exciting area of medicine: IVL therapy.”
