Minneapolis Heart Institute® Physician Serves as National PI in Research Trial Aiming to Improve Outcomes for Those with Peripheral Arterial Disease
Timothy Sullivan, MD is the first
physician in Minneapolis Heart Institute Foundation® history to serve as a
National PI leading the MIMICS-2 Trial.
MINNEAPOLIS, MINNESOTA –July 21, 2015 – Peripheral Arterial Disease (PAD) affects more than a quarter of a billion individuals globally. In fact, this disease has exhibited exponential growth of more than 20% in the past decade alone. In the United States, Medicare-funded, in-patient costs for PAD are estimated at $4 billion annually. PAD arises when blood vessels in the leg are blocked, decreasing blood flow in the leg and causing significant pain and, in severe cases, amputation. PAD increases with age and the presence of obesity or diabetes, both of which are rising in our population. Individuals with PAD have an increased risk of heart attack, stroke and death.
Timothy Sullivan, MD, Chairman of Vascular/Endovascular Surgery at Minneapolis Heart Institute® at Abbott Northwestern Hospital, is an expert in vascular surgery and has been conducting research through the Minneapolis Heart Institute Foundation® (MHIF) on this and other vascular conditions. Because of his expertise in the field, he has been selected as the National Principal Investigator (PI) for the MIMICS-2 trial, a trial that will test the safety and efficacy of the BioMimics 3D Nitinol Stent system. Dr. Sullivan will work with the European PI and the device manufacturer, Veryan, over the next two years in this phase. Sullivan notes, “Being selected as National PI for the MIMICS-2 trial is exciting. The device “mimics” the natural shape and function of the peripheral arteries, specifically by imparting a natural 3D helical shape on the artery. If proven efficacious, this not only would provide mechanical compatibility benefits but also would induce swirling blood flow that has been shown to be patency protective.” In addition, Veryan Chief Executive Officer Chas Taylor notes, “Webelieve this stent design offers possible benefits in femoropopliteal use and has potential for innovationin many other areas of endovascular intervention.”
As national PI, Dr. Sullivan will direct the research efforts of 30 sites across the United States, ensuring adherence to protocol and sharing results at national conferences. MHIF will also serve as a research site with vascular surgeon Elliot Stevenson, MD serving as the local study principal investigator.
About MIMICS-2
MIMICS-2 is a prospective, single-arm, multicenter clinical trial of 280 subjects with symptomatic atherosclerotic disease of the femoropopliteal artery. The study will be conducted in up to 40 centers in the US and Europe.
About the BioMimics 3D™ Nitinol Stent System
The BioMimics 3D nitinol stenthas unique helical curvature to impart natural curvature to the diseased artery, promoting secondary (swirling) flow and elevated wall shear stress, which has a protective effect on the endothelium. The helical geometry of the BioMimics 3D femoropopliteal stent is also designed to enable coil-springshortening of the stented segmentduring knee flexionand mitigate the risk of stented segmentcompression causing localized strains that in a straight stent may lead to stent fracture and chronic vascular injury.
Source: Minneapolis Heart Institute Foundation
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