REALITY Study to Evaluate Use of Directional Atherectomy and Drug Coated Balloon in Patients with Peripheral Arterial Disease

VIVA Physician Sponsored Study to Determine the Benefits of Debulking Plaque and Maximizing Luminal Gain Prior to Drug Coated Balloon Therapy

DUBLIN and LAS VEGAS., Medtronic plc announced today the initiation of the REALITY Study (DiRectional AthErectomy + Drug-coAted BaLloon to Treat Long, Calcified FemoropopliTeal ArterY Stenoses) to evaluate patient outcomes following adjunctive use of directional atherectomy and drug-coated balloon (DCB) treatment of patients with symptomatic peripheral arterial disease (PAD) in long, calcified lesions in the superficial femoral artery (SFA) and/or popliteal artery. The study is sponsored and will be managed by VIVA Physicians, and will have multidisciplinary representation in leadership.

The REALITY Study is a multi-center, prospective, single-arm observational angiographic and duplex ultrasound core lab adjudicated study that will enroll 250 subjects at up to 20 sites across the U.S. with primary patency assessed by duplex ultrasound at 12-months. Patients will be followed to 24 months to determine CD-TLR. Medtronic's directional atherectomy systems and IN.PACT^® Admiral^® drug-coated balloon will be studied in REALITY. The study also includes several important core lab adjudicated sub-analyses including the intravascular ultrasound assessment of the efficiency of directional atherectomy to debulk various plaque morphologies including severe calcium in long lesions prior to DCB deployment and the validation of the Peripheral Arterial Calcium Scoring Scale (PACSS) to assess the impact of severe vessel calcification on Major Adverse Clinical Events (MACE) from the procedure through 12 months. Importantly, a health economics and Quality of Life assessment will also be included as part of REALITY.

"As standalone treatments for peripheral arterial disease, directional atherectomy and DCBs have demonstrated strong clinical results. However, challenges in treating long and severely calcified femoropopliteal lesions remain including the associated provisional stent rate with DCB and reintervention rates with directional atherectomy over the long-term," said Dr. Krishna Rocha-Singh, chief scientific officer, Prairie Heart Institute at St. John's Hospital; Springfield, Ill. "The REALITY study was driven by the need to look at a viable treatment paradigm that combines the use of directional atherectomy and DCB therapy to address these challenges."

At VIVA 2014, Covidien (now Medtronic) presented the one-year results from the DEFINITIVE AR pilot study, which showed early promise in calcified and long lesions for PAD patients treated with directional atherectomy prior to DCB use.

"DEFINITIVE AR was the first, and only randomized pilot study to determine the outcome differences between patients who were treated with directional atherectomy and DCB and DCB alone. While the data demonstrated positive, early trends towards combination therapy in some lesion subsets,  further investigation is needed to determine the effectiveness of debulking a lesion with directional atherectomy prior to DCB," said Dr. Mark Turco, medical director of the Aortic & Peripheral Vascular Business within Medtronic's Cardiac and Vascular Group. "It is an honor for Medtronic to partner with VIVA and a multi-disciplinary team of clinicians in the study. We are pleased to support research in advancing therapy options for patients with PAD."

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

Source: Medtronic plc.