Expanding its commitment to developing innovative treatments for cardiovascular disease and the evidence to support their adoption, Medtronic, Inc. (NYSE: MDT) announced today the start of the Medtronic IN.PACT SFA II study, the company’s first U.S. clinical trial for its line of IN.PACT drug-eluting balloons.
The first patients in this landmark study were treated this week by Dr. Ash Jain at Washington Hospital in Fremont, Calif., and Dr. Brian Bigelow at St. Vincent Hospital in Indianapolis; Dr. Monica Hunter at Christ Hospital in Cincinnati is planning to treat a patient in the study as early as next week. Drs. Jain, Bigelow and Hunter are the principal investigators at their respective trial site.
Peripheral artery disease is estimated to affect eight to 12 million people in the United States alone. A prevalent form of cardiovascular disease, lower-extremity peripheral artery disease is a prime cause of claudication (ischemic leg pain) and immobility, critical limb ischemia and amputations.
The Medtronic IN.PACT SFA II study will evaluate the safety and effectiveness of the company’s IN.PACT Admiral drug-eluting balloon in the treatment of peripheral artery disease in the superficial femoral artery and/or proximal popliteal artery. Specifically, the trial will examine the effect of this novel device for treating de novo and non-stented restenotic atherosclerotic lesions in these vessel beds.The Medtronic IN.PACT SFA II study is a prospective, multicenter randomized controlled trial that will involve several hundred patients at up to 55 U.S. sites. Patients will be randomized 2:1 to treatment with either Medtronic’s IN.PACT Admiral drug-eluting balloon (study arm) or a traditional non-coated angioplasty balloon (control arm). The principal investigators of the Medtronic IN.PACT SFA II study are interventional cardiologist Dr. John Laird, professor of medicine at the University of California Davis and medical director of the UC Davis Vascular Center, and vascular surgeon Dr. Peter Schneider, chief of the vascular therapy division at Kaiser Foundation Hospital and Hawaii Permanente Medical Group in Honolulu.
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