Amplitude Vascular Systems (AVS) today announced findings from the first 95 patients treated in its POWER PAD II U.S. pivotal study.
POWER PAD II evaluates the company’s pulsatile intravascular lithotripsy (PIVL) therapy. It assesses the safety and efficacy of the Pulse IVL system for treating moderate-to-severely calcified peripheral arterial disease. Dr. Chris Metzger presented findings at the Vascular InterVentional Advances (VIVA) meeting in Las Vegas.
“The POWER PAD II study has provided outstanding safety and efficacy data in 95 patients at 30 days,” Metzger said. “The efficient treatment effect provided by the unique mechanism of action of the Pulse IVL system has shown clear benefit to these difficult-to-treat patients.”
Waltham, Massachusetts–based AVS received FDA investigational device exemption for its Pulse system last year. It enrolled the first patient in the study just over a year ago.
Pulse IVL features a unique mechanism of action, using high-frequency pulsatile pressure waves to fracture arterial calcium. AVS hopes to provide a new tool to help restore blood flow with improved deliverability and an intuitive design.
IVL remains a hot space, with Johnson & Johnson acquiring Shockwave Medical, a leader in IVL, for $13 billion last year.
Other companies, such as FastWave Medical, Elixir Medical and Vantis Vascular are making waves in IVL, too. Boston Scientific recently joined the fray with its acquisition of Bolt Medical, too. Abbott is making its own IVL play, too, advancing its own system.
A look at the results from AVS
POWER PAD II had a primary safety endpoint of freedom from major adverse events (MAEs) within 30 days following the index procedure. Investigators defined MAEs as emergent surgical revascularization, unplanned target limb amputation, symptomatic thrombus or distal emboli, or severe dissection or perforation requiring urgent intervention.
The study had a primary effectiveness endpoint defined as final residual diameter stenosis <50%. Through 30 days, investigators reported one MAE (unplanned target limb major amputation). All but one (94 of 95) subjects had a final residual stenosis <50%.
Metzger said the results proved pleasing, given the complexity of the patients treated. The population included 100% severely calcified lesions.
“AVS is the only company to conduct an above-the-knee (ATK) intravascular lithotripsy pivotal IDE study in the U.S., and we were very pleased with the initial findings,” said Elizabeth Galle, VP of clinical affairs at AVS. “This marks our most significant clinical milestone to date as we approach potential FDA clearance for the Pulse IVL system. We are confident in our innovative technology, and these positive results reinforce our belief in the benefits of Pulse IVL for the treatment of significant calcific disease.”
AVS plans to use the findings from the successful treatment of the first 95 patients to support an FDA 510(k) submission.
“We are thrilled with the results of the POWER PAD II pivotal study and are grateful to all of the investigators, research and hospital staff, as well as the patients involved,” said Mark Toland, chair of the board of AVS. “The results of this pivotal study will pave the way for our FDA 510(k) submission and the potential commercial availability of this unique approach to IVL therapy.”
