DISRUPT PAD Study Results Presented for Shockwave Medical's Lithoplasty System

April 27, 2016—Shockwave Medical announced that positive clinical results from the pooled DISRUPT PAD study were presented at the 2016 Charing Cross Symposium in London, United Kingdom.

The single-arm, two-phase multicenter study is evaluating the safety and performance of the company’s Lithoplasty system to treat peripheral artery disease (PAD). Prof. Thomas Zeller, MD, the study’s Principal Investigator, presented results from 95 patients, who were enrolled at eight sites, with calcified vascular stenosis of the superficial femoral artery and popliteal artery. Prof. Zeller is Head of the Department of Angiology at Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany.

According to Shockwave Medical, acute procedure results continue to demonstrate that the Lithoplasty technology provides successful and safe treatment of patients with calcified PAD, a difficult-to-treat population. Primary efficacy results demonstrated 100% acute success, defined as the ability to achieve < 50% residual stenosis using Lithoplasty with or without adjunctive angioplasty. 

The company noted that there was an average residual stenosis of 24%, with no difference in the ability to dilate lesions between moderate (44%) and severely (55%) calcified lesions. Stent utilization due to a flow-limiting dissection after Lithoplasty was 1% (1/95 patients) with no stents placed for efficacy reasons. Thirty-day patency assessed by duplex ultrasound was 100% with interim 6-month follow-up, demonstrating patency of 81%. 

In Shockwave Medical’s press release, Prof. Zeller commented, “The results we have seen with the Lithoplasty system show consistent procedural success, high acute gain, minimal vessel injury, and remarkably low use of implants. We also continue to see sustained functional improvement through 6 months with consistent effectiveness across all subgroups. These results are very encouraging.”

The company stated that the Lithoplasty system uses integrated lithotripsy emitters that generate mechanical pulse waves to disrupt both superficial and deep calcium normalizing vessel wall compliance before low-pressure balloon dilatation. The Lithoplasty device is built on a traditional balloon catheter platform

Shockwave Medical has received European CE Mark approval for use of the Lithoplasty System in the treatment of peripheral vascular disease. Clinical work has also been conducted in coronary vessels and aortic valves. The Lithoplasty system is not available for sale in the United States, advised the company.