Medtronic commences new study of peripheral artery disease treatment regimen

Medtronic has enrolled the first patient in a study assessing the benefits of a new approach to treating peripheral artery disease.

Allying with VIVA Physicians, Medtronic is launching the REALITY study to assess outcomes among patients with significantly calcified and symptomatic femoropopliteal peripheral artery disease following the adjunctive use of directional atherectomy and drug-coated balloons.

The company's HawkOne or TurboHawk system will be used in conjunction with its IN.PACT Admiral drug-coated balloon in the study, which will enroll up to 250 subjects at as many as 15 sites across the US and Germany.

Primary patency will be assessed by duplex ultrasound at 12 months, with patients to be followed up to 24 months to determine clinically-driven target lesion revascularisation.

Mark Pacyna, vice president and general manager of Medtronic's peripheral business, said: "This study is designed to further refine the peripheral artery disease treatment algorithm by providing greater evidence for vessel preparation with directional atherectomy prior to treatment with drug-coated balloons."

Last week, the firm announced that it has been granted European CE Mark approval for its new Guardian Connect mobile continuous glucose monitoring system, for use in the treatment of diabetes.