Boston-based Amplitude Vascular’s POWER PAD II clinical study evaluates the safety of the Pulse IVL system. The company’s pulsatile IVL (PIVL) therapy treats patients with moderate to severely calcified peripheral arterial disease. It received FDA investigational device exemption earlier this year.
Dr. Nicolas W. Shammas conducted the first case at UnityPoint Trinity Medical Center in Bettendorf, Iowa. Amplitude Vascular expects the trial to enroll up to 120 subjects, following them for up to six months at up to 20 U.S. facilities.
The IVL space is an interesting one, with Johnson & Johnson acquiring Shockwave Medical, a leader in IVL, for $13 billion this year. Dr. Chris Metzger, the POWER PADD II principal investigator, called Amplitude Vascular’s offering “a new, innovative treatment for calcified arterial disease.”
Shammas found the device “very deliverable and incredibly efficient.” He said it effectively modified calcium and ultimately restored blood flow to the first patients’ vascular system.
“AVS is one of the first companies to conduct a peripheral intravascular lithotripsy pivotal IDE trial in the U.S., and this patient is the first of many U.S. patients who will benefit from our innovative technology,” said Elizabeth Galle, VP 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.”
