US-based developer of lithoplasty technology, Shockwave Medical has reported positive results from the pooled DISRUPT PAD study while assessing the safety and performance of Lithoplasty System to treat peripheral artery disease.
The single-arm, two-phase multicentre study involved eight sites and 95 patients with calcified vascular stenosis of the superficial femoral artery (SFA) and popliteal artery, who were examined by Universitäts-Herzzentrum Freiburg-Bad Krozingen angiology department head Thomas Zeller.
The results are said to have demonstrated a safe and successful treatment of patients with calcified peripheral artery disease leveraging on lithoplasty technology.
Primary efficacy results exhibited 100% acute success, defined as the ability to achieve less than 50% residual stenosis using lithoplasty with or without adjunctive angioplasty.
Shockwave Medical CEO and co-founder Daniel Hawkins said: "The positive results of the DISRUPT PAD programme 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."
The Lithoplasty technology combines the calcium-disrupting power of lithotripsy with simple balloon-based interventional devices, using the integrated lithotripsy emitters to issue mechanical pulse waves to disrupt both superficial and deep calcium. This normalises vessel wall compliance prior to low-pressure balloon dilatation.
It is said to target only the superficial calcium without affecting deep calcium, causing reduced soft tissue injury and restoring blood flow.