Christopher Metzger (Ballad Health CVA Heart Institute, Kingsport, USA) reported at the 2025 Vascular Interventional Advances (VIVA) conference (2–5 November, Las Vegas, USA) that the Pulse intravascular lithotripsy (IVL) system (Amplitude Vascular Systems) successfully treated severely calcified femoropopliteal disease in a pivotal investigational device exemption (IDE) study.
The POWER PAD II study is a prospective, multicentre, single-arm study designed to demonstrate the safety and effectiveness of the Pulse IVL system for treatment of calcified, stenotic superficial femoral and popliteal arteries in patients with peripheral arterial disease (PAD). Eligibility criteria included moderate to heavily calcified superficial femoral and popliteal arterial disease, Rutherford category 2–4 symptoms, reference vessel diameter of 4–6.5mm, and total lesion length of ≤150mm.
Patients were enrolled at sites in the USA and followed for six months. The primary effectiveness endpoint was the proportion of patients who achieved a residual diameter stenosis of <50% post Pulse IVL procedure and after adjunctive therapy. The primary safety endpoint was freedom from major adverse events (MAEs) within 30 days from the Pulse IVL procedure, defined as emergency surgical revascularisation of target limb, unplanned target limb amputation, symptomatic thrombus or distal emboli, or perforations or dissections of grade D or greater that require bailout stenting. An independent core lab adjudicated all angiograms at the time of the procedure, and an independent clinical events committee reviewed all adverse events.
On primary effectiveness, Metzger reported at VIVA 2025 that <50% stenosis was achieved in 94 out of 95 patients. He also noted a mean of 80 seconds of therapy per patient and that a majority (75%) of treatment effect was due to IVL therapy.
With regard to primary safety, the presenter shared that 94 out of 95 patients included in the pivotal IDE study were free from adverse events at 30 days.
“These findings support the safety and effectiveness of the Pulse IVL system for the treatment of calcific femoropopliteal disease,” Metzger concluded.
