Shockwave Medical's Lithoplasty Balloon Catheters Evaluated in DISRUPT PAD

November 5, 2014—Shockwave Medical announced clinical results from DISRUPT PAD, a single-arm, multicenter study evaluating the safety and utility of the company’s Lithoplasty balloon catheters for the treatment of peripheral artery disease, at the VIVA 2014: Vascular Interventional Advances meeting in Las Vegas, Nevada. DISRUPT Principal Investigator Marianne Brodmann, MD, of the Medical University of Graz in Austria, presented the results.

According to the company, Lithoplasty is a balloon-based technology that utilizes integrated lithotripsy, a pulsatile mechanical energy commonly used to break up kidney stones, to disrupt both superficial and deep calcium and normalize vessel wall compliance prior to low-pressure balloon dilatation. Lithoplasty is designed to be naturally gentle to soft tissue (nondiseased portions of the vessel) while remaining hard on calcium, the tissue that limits vessel expansion and the effectiveness of current technologies.

The company stated that early clinical evaluation from 35 patients with calcified vascular stenosis of the superficial femoral artery (SFA) and popliteal artery demonstrated safe and effective dilatation of calcified stenosis with no acute failures, favorable residual stenosis, and no reintervention out to 30 days, with no major adverse events. Primary efficacy results demonstrated 100% success, defined as ability to achieve less than 50% residual stenosis using Lithoplasty with or without adjunctive angioplasty. Device success was 87%, defined as ability to achieve less than 50% residual stenosis using Lithoplasty alone. Additionally, there was an average residual stenosis of 23% (initial 76%), with no difference in the ability to dilate lesions between moderate (36%) and severely (64%) calcified lesions. Thirty-day patency assessed by duplex ultrasound was 100%.

“Calcified vascular lesions remain a major impediment to modern percutaneous therapy for vascular disease,” said Marianne Brodmann, MD. “The results of this trial demonstrate that, unlike current devices that treat only superficial calcium, Shockwave’s Lithoplasty system promises to be effective on all types of calcium, including deep calcium—the type known to limit vessel expansion.”

The company noted that in September, results from the first-in-man study of five patients with moderate to severe coronary calcification were presented at the TCT 2014: the 26th annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC. Those results demonstrated safety, tolerability, deliverability, and effectiveness for Lithoplasty as a pretreatment of calcified coronary lesions prior to stenting.