(NYSE: COV), a leading global provider of healthcare products, today announced the completion of patient enrollment in its iliac stent clinical study series. The series is composed of two prospective, multinational, 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.
According to the American Heart Association, approximately eight million people in the U.S. suffer from PAD
, which affects blood vessels throughout the body. When the vessels become clogged with plaque, blood flow slows or stops. If left untreated in vessels either leading to or located in the legs or feet, this condition can lead to severe pain when walking, gangrene and even amputation.
“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, MD, 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.”
VISIBILITY Iliac and DURABILITY Iliac Study Designs
VISIBILITY Iliac and DURABILITY Iliac are prospective studies being conducted at 23 centers in the U.S. 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 Protégé™ 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.