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Covidien completes patient enrollment in peripheral arterial disease studies
Feb 28, 2013 (Datamonitor via COMTEX) --
Covidien plc, a provider of healthcare products, has announced the completion of patient enrollment in its iliac stent clinical study series. The series is composed of two prospective multicenter studies - VISIBILITY Iliac and DURABILITY Iliac.
Each study is designed to evaluate the safety and effectiveness of using either balloon expandable or self-expanding stents to treat peripheral arterial disease (PAD) in the common iliac and external iliac arteries. Located in the lower abdomen, the common iliac and external iliac arteries are the main conduits delivering blood to the arteries in the legs.
VISIBILITY Iliac and DURABILITY Iliac are prospective studies being conducted at 23 centers in the US and Europe. Of the 150 patients enrolled in the studies, 75 were treated with the Visi-Pro balloon expandable stent system in VISIBILITY Iliac, and 75 were treated with either the EverFlex self-expanding stent system or the Protege GPS self-expanding nitinol stent and delivery technology in DURABILITY Iliac.
Primary effectiveness of the stents and incidence of major adverse events will be evaluated through nine months, and patients in the study will be followed for a total of three years, the company said.
"We are very pleased to report the completion of enrollment in these two studies, as the results will add important clinical data around treatment for patients with PAD," said Mark A. Turco, chief medical officer, Vascular Therapies, Covidien. "The results of the studies will enable physicians to make evidence-based decisions to allow for optimal patient outcomes. Covidien remains committed to bringing clinical data to the forefront, while working toward obtaining important disease and anatomic- specific labeling indications for our products."
"The completion of enrollment in the VISIBILITY Iliac Study marks a significant milestone in the progress toward completion of this important Phase II trial," said Peter L. Faries, MD, Chief of Vascular Surgery at Mount Sinai School of Medicine in New York. "Enrollment was completed well ahead of schedule. We believe the rapid enrollment reflects both enthusiasm for the promise of this technology and the unique trial design that allowed treatment of concurrent infrainguinal occlusive disease if needed by the patient."
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