Six-Month DISRUPT PAD Results Reported for Shockwave's Lithoplasty System

September 19, 2016—Prof. Thomas Zeller, MD, presented findings from the DISRUPT PAD study of Shockwave Medical’s Lithoplasty system during the first Late-Breaking Trials session at VIVA 16, the 14th annual Vascular InterVentional Advances meeting, which is sponsored by VIVA Physicians, Inc. and being held September 18–22, 2016 at the Wynn Las Vegas in Las Vegas, Nevada.

Prof. Zeller explained that the Lithoplasty technology integrates the calcium-disrupting power of lithotripsy with the familiarity and simplicity of balloon-based interventional devices. Built on a traditional balloon catheter platform, Shockwave’s Lithoplasty devices use the intermittent pulsatile mechanical energy of lithotripsy to disrupt both superficial and deep calcium while minimizing soft-tissue injury and an integrated balloon to dilate lesions at low pressures, restoring blood flow.

The DISRUPT PAD study is a single-arm, two-phase, multicenter study that enrolled 95 patients with symptomatic, calcified femoropopliteal lesions ≤ 15 cm in length. The primary safety endpoint was freedom from major adverse events through 30 days. Procedural success, the primary performance endpoint, was defined as < 50% residual diameter stenosis, with or without adjunctive balloon angioplasty therapy. Key secondary endpoints included target lesion revascularization and vessel patency, defined as freedom from > 50% restenosis.

As summarized by Prof. Zeller at VIVA 16, clinical data from the study demonstrate compelling safety, consistent procedural success across all patient subgroups (including moderate and severe calcium), high acute gain, and minimal acute vessel injury results. Midterm results show sustained patency, target lesion revascularization, and functional improvement through 6 months. There were no major amputations, perforations, thrombus, or distal embolization events. 

There was 100% procedural success, with average residual stenosis of 24% and acute gain of 3 mm. Only one stent (1%) was implanted to treat a flow-limiting dissection. Vessel patency was 77% at 6 months as assessed by duplex ultrasound. Target lesion revascularization was only 3% at 6 months. 

The ongoing positive results of the DISRUPT PAD study demonstrate that the Lithoplasty technology is a promising treatment for patients with calcified peripheral artery disease, which is often difficult to treat, concluded Prof. Zeller at VIVA 16.

Shockwave Medical announced on September 16 that the US Food and Drug Administration has cleared the Lithoplasty system for the treatment of calcified plaque in patients with PAD. The company plans a limited commercial release in the United States in 2017. The Lithoplasty system, which received CE Mark approval in 2015, is commercially available in Europe.