Shockwave Medical announced positive clinical results from the DISRUPT PAD study evaluating the safety and utility of Lithoplasty balloon catheters for the treatment of peripheral artery disease, at the Vascular Interventional Advances (VIVA) Annual Conference in Las Vegas, USA.
Lithoplasty is a novel balloon-based technology that utilises integrated lithotripsy to disrupt both superficial and deep calcium and normalise vessel wall compliance prior to low-pressure balloon dilatation.
Early clinical evaluation from 35 patients with calcified vascular stenosis of the superficial femoral artery and popliteal artery demonstrated safe and effective dilatation of calcified stenosis with no acute failures, favourable residual stenosis, and no re-intervention 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. Importantly, 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, was noted. Thirty-day patency assessed by duplex ultrasound was 100%.
“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,” says Marianne Brodmann, of the Medical University of Graz, Austria, principal investigator of the study, who presented the results at the conference.
“We are excited about these excellent results, which suggest that Lithoplasty technology can address a substantial unmet clinical need in a large subset of patients with peripheral artery disease,” said Shockwave Medical chief executive officer and co-founder Daniel Hawkins. “These results build upon the findings from our coronary first-in-man study presented earlier this fall at the Transcatheter Cardiovascular Therapeutics conference, which demonstrated the promise of Lithoplasty for the treatment of calcified coronary lesions. We look forward to confirming these promising findings in additional future studies, including the European multi-centre DISRUPT CAD study planned for next year.”