Medtronic plc announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate a study of the IN.PACT® Admiral® drug-coated balloon (DCB) for a potential new indication in patients with end-stage renal disease. The randomized study will evaluate the IN.PACT Admiral DCB as a treatment for failing arteriovenous (AV) fistulas in these patients as compared to plain balloon angioplasty. The IDE approval enables Medtronic to initiate the study and gain safety and effectiveness data for the device in this investigational indication. Globally, more than 2.5 million patients with end-stage renal disease are undergoing dialysis, a procedure that filters waste and removes extra fluid from the blood when the kidneys are no longer healthy. AV access sites are used to provide hemodialysis to patients. Over time, thickening of the vessel walls limits the ability to use a dialysis access site, requiring repeat interventions, which increase health care utilization and reduce quality of care. Repeated procedures are also associated with high technical failure rates and reduced quality of life for patients. The IDE study will evaluate the safety and efficacy of the IN.PACT DCB for up to two years at approximately 30 sites in United States, Japan, and New Zealand. Principal Investigators include: Dr. Holden, Robert Lookstein, M.D., professor of radiology and surgery, vice-chair of interventional services, and medical director of clinical supply chain at Mt. Sinai Healthcare System, and Hiroaki Haruguchi, M.D., clinic director at Haruguchi Vascular Clinic. The study will aim to enroll 330 patients with a 2:1 randomization to either treatment with IN.PACT Admiral DCB or standard balloon angioplasty. The primary efficacy endpoint is patency of dialysis fistulas through six months and the primary safety endpoint is major adverse events through 30 days. Additional endpoints include reducing access circuit related events including repeat procedures.