Shockwave Medical is reporting positive 6-month results from study of its "lithoplasty" balloon catheter for treating peripheral artery disease, saying the device passed its efficacy and safety measures with flying colors.
Results from the 35-patient study were presented last month at the Charing Cross International Symposium in London, Fremont, Calif.-based Shockwave said. The device is designed to use "pulsatile mechanical energy" to "disrupt both superficial and deep calcium and normalize vessel wall compliance" before a low-pressure balloon dilation, according to the company.
The Disrupt PAD study showed a 100% primary efficacy rate, defined as less than 50% residual stenosis with or without adjunctive angioplasty (device success was 87% using lithoplasty alone), Shockwave said. Freedom from re-intervention was 100% and duplex ultrasound-assessed patency was 83%.
"These exciting results create a new benchmark for the treatment of calcified peripheral vascular disease. These patients are some of the most difficult to treat. The results of the Disrupt PAD study exceeded those typically observed with traditional balloon angioplasty and atherectomy approaches, which often require the use of adjunctive drug-coated balloon treatment or stenting," co-founder Dr. Todd Brinton said in a press release.
In January 2015, Shockwave received CE Mark approval for the lithoplasty balloon device, supported by data from Disrupt PAD that were presented in November 2014 at the Vascular Interventional Advances annual conference.
"We are excited about these results, which confirm Lithoplasty technology can address a substantial unmet clinical need in a large subset of patients with peripheral artery disease using an intuitive and inherently familiar balloon-based therapy. We look forward to broadening the clinical evidence on the performance of Lithoplasty with additional studies, including the European multi-center DISRUPT CAD study for the treatment of coronary artery disease planned for later this year," added CEO & co-founder Daniel Hawkins.