POWER PAD II Study of Pulse IVL System Meets Endpoints

October 16, 2026—Results from the prospective, single-arm, multicenter POWER PAD II study demonstrated that the Pulse intravascular lithotripsy (IVL) system (Amplitude Vascular Systems, Inc., recently acquired by Stryker) met its primary safety and effectiveness endpoints in patients with calcified femoropopliteal artery disease. The findings were presented by Jon C. George, MD, at VIVA 2026, the Vascular Interventional Advances conference.

According to the study summary from VIVA, the investigational device exemption (IDE) study evaluated the safety and effectiveness of the Pulse IVL system for treating calcified femoral and popliteal arteries in patients with peripheral artery disease (PAD). Early findings from the study were presented last year by Chris Metzger, MD, at VIVA 2025.

According to the VIVA press release, the study enrolled and treated 115 patients (mean age, 72 years; male, 65%) at 17 United States sites. Approximately 75% of patients had Rutherford class 3 disease, and most had a history of hypertension and dyslipidemia.

All treated lesions (mean length, 86 mm; mean diameter stenosis, 82%) met the Peripheral Academic Research Consortium (PARC) definition of severe calcification. Most lesions were located in the superficial femoral artery (72%). Both concentric and eccentric calcium were present in 70% of lesions.

As reported by VIVA, for the primary effectiveness endpoint, 98.3% of patients achieved final residual diameter stenosis < 50%. For the primary safety endpoint, 98.3% of patients were free from new-onset major adverse events within 30 days after the procedure. No serious device-related adverse events were reported.

The study further found that results were sustained through 6 months of follow-up. Patency was 94% at 30 days and 91% at 6 months. The proportion of patients with Rutherford class improvement increased from 88% at 30 days to 93% at 6 months. Mean ankle-brachial index increased from 0.76 at baseline to 0.99 at both 30 days and 6 months. No patients required clinically driven target lesion revascularization during follow-up.

The POWER PAD II findings support the feasibility of using the Pulse IVL system to treat severely calcified femoropopliteal lesions, concluded the study summary from VIVA.