Medtronic (NYSE:MDT) said yesterday it enrolled the 1st patients in the VIVA-sponsored Reality study assessing outcomes of peripheral artery disease patients treated with directional atherectomy and drug-coated balloons.
The study is slated to enroll up to 250 subjects across 15 sites, investigating the use of Medtronic’s HawkOne, TurboHawk and In.Pact Admiral DCB for calcified and symptomatic femoropoliteal PAD patients, Fridley, Minn.-based Medtronic said.
“PAD is a complex and progressive disease. The severity of the disease can often have an impact on treatment options for patients. Long lesion length and severe calcification are obstacles that challenge both our ability to gain acute luminal gain and to maintain long-term patency. Reality is driven by the need to look at a viable treatment paradigm that combines the use of directional atherectomy and DCB therapy to address the challenges of treating complex PAD,” co-principal investigator Dr. Krishna Rocha-Singh of the Prairie Heart Institute of Illinois said in a press release.
The study plans to include angiographic and duplex ultrasound core lab adjutication, with primary patency assessed by duplex ultrasound at 12 months. Patients in the trial will be followed up to 24 months post-procedure to explore clinically driven target lesion revascularization rates.
“We know that directional atherectomy and DCB perform well as standalone treatments; and early data suggests that combined therapy may improve patient outcomes in more complex lesions. Through Reality we hope to answer this critical question with rigorous clinical data in this well designed study,” Dr. Roger Gammon of the Austin Heart Central-Heart Hospital, who treated the 1st patient enrolled in the study, said in prepared remarks.
“Medtronic is committed to improving patient lives through unique clinical partnerships, exemplified by the Reality study. This study is designed to further refine the PAD treatment algorithm by providing greater evidence for vessel preparation with directional atherectomy prior to treatment with DCB,” Medtronic peripheral biz GM Mark Pacyna said in prepared remarks.
