Six-Month DISRUPT PAD Results Presented for Shockwave Medical's Lithoplasty

September 19, 2016—Shockwave Medical announced positive clinical results from the pooled DISRUPT PAD study, a single-arm, two-phase, multicenter study evaluating the safety and performance of the company’s Lithoplasty system in calcified peripheral lesions. Principal investigator Prof. Thomas Zeller, MD, presented the data at VIVA 16, the Vascular InterVentional Advances annual conference in Las Vegas, Nevada. Prof. Zeller is Head of the Department of Angiology at Universitäts-Herzzentrum Freiburg-Bad in Krozingen, Germany.

In the DISRUPT PAD study, 95 patients with symptomatic femoropopliteal lesions up to 15 cm in length were enrolled at 11 sites. The study’s 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, target lesion patency by duplex ultrasound defined as freedom from > 50% restenosis, and functional outcomes.

In the company’s press release, Prof. Zeller stated, “The ongoing positive results from DISRUPT PAD demonstrate that Lithoplasty technology is a promising treatment for patients with calcified peripheral artery disease (PAD), a difficult-to-treat population. After 6 months of follow-up, we have documented consistent and predictable procedural success, high acute gain, minimal vessel injury, and remarkably low need for additional implants."

According to the company, clinical data from the study demonstrate compelling safety with no major amputations, perforations, thrombus, or distal embolization events. Stent utilization due to a flow-limiting dissection after Lithoplasty was limited to 1% in the study population composed of moderate or severely calcified lesions. Primary effectiveness results demonstrated 100% procedural success defined as residual stenosis < 50%.

In addition, an exploratory endpoint of procedural success defined as residual stenosis < 30% was achieved in 89.5% of lesions, with an average residual stenosis of 24% and acute gain of 3.0 mm (average RVD of 5.5 mm). Six-month patency assessed by duplex ultrasound was 77% with target lesion revascularization of 3.2%.

The company advised that the Lithoplasty system is commercially available in the European Union and the United States for treatment of peripheral vascular disease.

On September 16, Shockwave announced US Food and Drug Administration clearance of the Lithoplasty system for the treatment of calcified plaque in patients with PAD. Shockwave Medical plans a limited commercial release of the Lithoplasty system in the United States in 2017 and will initiate a global randomized trial to gather further clinical data on the benefits of treatment with the device. In 2015, the company announced CE Mark approval for the Lithoplasty system, which is commercially available in Europe.