FREMONT, Calif. & LONDON--(BUSINESS WIRE)--Please replace the release with the following corrected version due to multiple revisions.
The corrected release reads:
SHOCKWAVE MEDICAL ANNOUNCES POSITIVE SIX-MONTH RESULTS FROM STUDY OF NOVEL LITHOPLASTY SYSTEM FOR THE TREATMENT OF PERIPHERAL ARTERY DISEASE
Data Presented at Charing Cross Symposium 2015 Show Continued Safety and Effectiveness
Shockwave Medical, a pioneer in the treatment of peripheral and coronary vascular disease, today announced positive six-month clinical results from DISRUPT PAD, a single-arm multicenter study evaluating the safety and utility of Lithoplasty® balloon catheters for the treatment of peripheral artery disease, at the 37th Annual Charing Cross 2015 Symposium in London.
Results from 35 patients with calcified vascular stenosis of the superficial femoral artery (SFA) and popliteal artery were presented by co-principal investigator Andrew Holden, MBChB, Director of Interventional Radiology at Auckland Hospital in Auckland, New Zealand.
“These data, which show sustained clinical benefits with no re-intervention at six months, follow the ‘stent-like’ acute procedural results presented last fall at the Vascular Interventional Advances (VIVA) Annual Conference in Las Vegas, Nevada,” said Dr. Holden.
The results from DISRUPT PAD demonstrate safe and effective dilatation of calcified stenosis with no acute failures, favorable residual stenosis, no major adverse events and no need for stent placement. At six months, freedom from re-intervention was 100% and patency assessed by duplex ultrasound was 83%. 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% 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.
“These exciting results create a new benchmark for the treatment of calcified peripheral vascular disease,” said Todd Brinton, M.D., Clinical Associate Professor of Medicine at Stanford and co-founder of Shockwave Medical. “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.”
In advanced vascular disease, atherosclerosis becomes calcified deep inside the vessel walls, limiting blood flow. These deposits are difficult to treat because they limit the effectiveness of current endovascular devices, making today’s interventions challenging and prone to both procedural and long-term failure. Lithoplasty is a novel 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 (non-diseased portions of the vessel) while remaining hard on calcium, the tissue that limits vessel expansion and the effectiveness of current technologies.
“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,” said Shockwave Medical CEO and co-founder Daniel Hawkins. “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.”
About Shockwave’s Lithoplasty® System
Unlike current devices that treat only superficial calcium, Shockwave’s Lithoplasty system is designed to be effective on all types of calcium, including deep – the type known to limit vessel expansion. Delivered on a standard balloon catheter platform, Lithoplasty combines the calcium disrupting power of lithotripsy with the familiarity and simplicity of a balloon in a single enabling device. Lithoplasty applies a brief series of powerful mechanical pulses designed to safely travel through soft tissue, disrupt and pre-treat calcium. The integrated balloon is then dilated at low pressures to expand the lesion evenly, potentially minimizing acute soft tissue injury that could lead to the need for additional interventional treatments, or long-term restenosis (re-blockage).
Early clinical results demonstrate safety, tolerability, deliverability, and effectiveness for Lithoplasty as a treatment for patients with peripheral artery disease and as a pre-treatment of calcified coronary lesions prior to stenting. Shockwave has received CE Mark for use of Lithoplasty in the treatment of peripheral vascular disease. Clinical work has also been conducted in coronary vessels, and will begin in aortic valves later this year.
Lithoplasty is not available for sale in the United States.
To view an animation of Lithoplasty visit http://shockwavemedical.com/technology.
About Shockwave Medical
Shockwave Medical, based in Fremont, Calif., is pioneering Lithoplasty® technology, a promising breakthrough for the treatment of peripheral and coronary vascular disease and aortic stenosis. Delivered on a standard balloon catheter platform, Lithoplasty combines the calcium disrupting power of lithotripsy with the familiarity and simplicity of a balloon in a single enabling device. For more information visit www.shockwavemedical.com.
