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 Lithoplasty system to treat peripheral artery disease, at the 38th Annual Charing Cross 2016 Symposium in London.
Results from 95 patients with calcified vascular stenosis of the superficial femoral artery (SFA) and popliteal artery enrolled at eight sites were presented by principal investigator Thomas Zeller, M.D., head of the Department of Angiology at Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany.
Acute procedure results on the entire cohort and interim follow up results for the DISRUPT PAD pooled study are in line with the DISRUPT PAD I findings presented at the Charing Cross Symposium last year and continue to demonstrate that the Lithoplasty Technology provides successful and safe treatment of patients with calcified peripheral artery disease, a difficult-to-treat population.
Primary efficacy results demonstrated 100% acute success, defined as ability to achieve less than 50% residual stenosis using Lithoplasty with or without adjunctive angioplasty.
Importantly, an average residual stenosis of 24%, with no difference in the ability to dilate lesions between moderate (44%) and severely (55%) calcified lesions, was noted. Stent utilization due to a flow limiting dissection following Lithoplasty was limited to 1% (1/95 patients) with no stents placed for efficacy reasons.
Thirty-day patency assessed by duplex ultrasound was 100% with interim six-month follow-up demonstrating patency of 81%.
"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," Dr. Zeller said. "We also continue to see sustained functional improvement through six months with consistent effectiveness across all subgroups. These results are very encouraging."
Arterial calcification is increasingly common with an aging population as cardiovascular disease has become a chronic condition due to improved disease management, preventive care, and lifestyle changes.
Traditional devices and techniques for treating occlusive calcified lesions generate suboptimal and unpredictable outcomes often leading to significant soft tissue damage requiring additional treatment.
The most advanced of these devices targets only superficial calcium, leaving deep calcium unaffected, frequently resulting in poor lesion dilation. Lithoplasty is a novel technology utilizing integrated lithotripsy emitters that generate mechanical pulse waves to disrupt both superficial and deep calcium normalizing vessel wall compliance prior to low-pressure balloon dilatation.
"The positive results of the DISRUPT PAD program reinforce our belief that the Lithoplasty System is uniquely suited to address substantial unmet needs in the treatment of patients with peripheral, coronary and heart valve disease, using a balloon-based approach that is inherently familiar to physicians," said Shockwave Medical CEO and co-founder Daniel Hawkins.