Medtronic commences directional atherectomy and drug-coated balloon study

Medtronic has announced the commencement of a new study evaluating the benefits of its directional atherectomy and drug-coated balloon treatments.

The newly-initiated REALITY study aims to evaluate patient outcomes following adjunctive use of directional atherectomy and drug-coated balloon treatment of patients with symptomatic peripheral arterial disease in long, calcified lesions in the superficial femoral artery and/or popliteal artery.

A total of 250 subjects will be enrolled at up to 20 sites across the US, with primary patency assessed by duplex ultrasound at 12 months and a follow-up after 24 months.

Medtronic's directional atherectomy systems and IN.PACT Admiral drug-coated balloon will be studied in REALITY, which is sponsored and will be managed by VIVA Physicians.

Dr Mark Turco, medical director of the aortic and peripheral vascular business within Medtronic's cardiac and vascular group, said: "It is an honour for Medtronic to partner with Viva and a multidisciplinary team of clinicians in the study. We are pleased to support research in advancing therapy options for patients with PAD."

The firm recently announced data from the IN.PACT SFA Trial showing the benefits of the IN.PACT Admiral drug-coated balloon in the treatment of peripheral arterial disease.