FDAnews Device Daily Bulletin
Medical Devices / Research and Development

Medtronic Announces Launch of REALITY Study for PAD

Nov. 4, 2015

A new study — dubbed REALITY — is now under way that will evaluate outcomes following the use of directional atherectomy and drug-coated balloon treatment in patients with peripheral arterial disease characterized by long, calcified lesions in the superficial femoral artery and/or popliteal artery, Medtronic announced this week.

The study, sponsored and managed by Viva Physicians, will enroll 250 patients at up to 20 sites around the U.S. Patients will be followed for 24 months.

Medtronic’s directional atherectomy devices are designed to remove a variety of plaque morphologies from the peripheral vessels in PAD patients and permit the restoration of blood flow.

The IN.PACT Admiral drug-coated balloon works to reopen superficial femoral and popliteal arteries narrowed or blocked by plaque. — Michael Cipriano