Medtronic Initiates Landmark U.S. Drug-Eluting Balloon Study

Medtronic, Inc.

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.