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Medtronic completes enrolment for new stent trial
Medtronic has completed the enrolment process for a forthcoming clinical trial of its new Complete SE (self-expanding) vascular stent.
The medical technology firm has signed up 196 patients with symptomatic, ischemic peripheral arterial disease (PAD) in order to evaluate the stent's efficacy in treating atherosclerosis in the superficial femoral artery.
Primary endpoints for the study are a reduction in the number of major adverse events, as well as measuring the patency of the stent at 12 months.
It is hoped that the new stent will offer a treatment option for a condition which often goes undiagnosed and unrecognised, despite its associated risk of disability and mortality.
Dr John Laird, medical director of the Vascular Center at the University of California and the study's US principal investigator, said: "Medtronic is partnering with physicians around the world to expand clinical knowledge about a potentially serious health condition, while at the same time generating data in support of the safety and efficacy of its Complete SE stent."
Earlier this month, Medtronic commenced a clinical trial named Defeat-HF, which aims to gauge the efficacy of neurostimulation as a means of combating chronic heart failure.
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