Shockwave Medical this week touted data from a 6-month study evaluating its Lithoplasty system as treatment for calcified peripheral lesions.
The Fremont, CA-based company said it enrolled 95 patients with femoropopliteal lesions at 11 sites in its Disrupt PAD study.
The company reported no major adverse events during the 6 month trial, including major amputations or perforations, and 100% procedural success. The trial met its primary performance endpoint of less than 50% residual diameter stenosis with or without adjunctive balloon angioplasty therapy.
Data indicated a 1% rate of stent utilization due to a flow limiting dissection following lithoplasty. The trial met its exploratory endpoint of a 30% or less rate of residual stenosis, touting an 89.5% rate with an average residual stenosis of 24% and acute gains of 3 mm. Patency, as assessed by duplex ultrasound, was 77% with a 3.2% rate of target lesion revascularization.
“The Disrupt PAD data continue to reinforce the potential of the Lithoplasty System to address the growing burdens of arterial calcification,” CEO and co-founder Daniel Hawkins said. “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.”
Over half of all patients with peripheral vascular disease have calcified lesions in their arteries, according to the study’s principal investigator, Dr. Thomas Zeller.
“The ongoing positive results from Disrupt PAD demonstrate that Lithoplasty technology is a promising treatment for patients with calcified peripheral artery disease, a difficult-to-treat population,” Zeller said in prepared remarks. “After six 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.”
The Lithoplasty system uses pulsatile mechanical energy to disrupt superficial and deep calcium, unlike traditional methods which can’t reach deep calcium. Using an integrated balloon to dilate lesions, the system minimizes soft tissue injury.
“We are very pleased with the durable success the Lithoplasty System has demonstrated in treating calcified peripheral artery disease,” co-founder Dr. Todd Brinton added. “We will continue to expand our global clinical program and look forward to working with physicians to further address the needs of patients with advanced cardiovascular disease.”
This comes 1 week after Shockwave Medical said it won 510(k) clearance from the FDA for the system to treat calcified plaque in patients with peripheral artery disease.