A single-arm study found that all of the patients with moderate or severely calcified peripheral lesions who received the lithoplasty system achieved the primary efficacy endpoint of procedural success.
The researchers defined procedural success as less than 50 percent residual diameter stenosis with or without adjunctive balloon angioplasty therapy.
Results of the DISRUPT PAD study were presented Sept. 16 at the Viva Physicians annual conference in Las Vegas.
The trial enrolled 95 patients at 11 sites who had symptomatic femoropopliteal lesions up to 15 cm in length. All patients received Shockwave Medical’s lithoplasty system, which the FDA approved on Sept. 16 to treat calcified plaque in patients with peripheral artery disease.
After six months of treatment, there were no major amputations, perforations, thrombus or distal embolization events, according to a Shockwave Medical news release. In addition, only 1 percent of patients had stent utilization due to a flow limiting dissection following lithoplasty.
Further, 89.5 percent of patients had residual stenosis of less than 30 percent. The mean residual stenosis was 24 percent.
Shockwave Medical plans on making the lithoplasty system available in the U.S. on a limited basis next year. The company said it would conduct a randomized trial to test the safety and efficacy of treatment with the lithoplasty system, as well.
“The DISRUPT PAD data continue to reinforce the potential of the Lithoplasty System to address the growing burdens of arterial calcification,” Shockwave Medical CEO and co-founder Daniel Hawkins said in a news release. “This data prepares us to further advance use of the technology for patients with peripheral disease as we embark on commercialization in the United States.”