Covidien Completes Patient Enrollment in Iliac Stent Clinical Study Series
VISIBILITY Iliac and DURABILITY Iliac Studies Evaluate the Safety and
Effectiveness of Balloon Expandable and Self-Expanding Stents in Treating
Iliac Artery Disease
MANSFIELD, Mass. -- February 20, 2013
Covidien (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^1, 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
“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.
“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.”
“Aortoiliac occlusive disease remains an important cause of vascular
disability,” added John H. Rundback, MD, Medical Director of the
Interventional Institute at Holy Name Medical Center in Teaneck, New Jersey.
“We believe the outcomes from the DURABILITY Iliac study will validate the
effectiveness of the self-expanding EverFlex and GPS stents, supporting the
role of endovascular treatment in patients with both simple and complex iliac
lesions to improve and maintain quality of life. The combined DURABILITY Iliac
and VISIBILITY Iliac studies will provide a comprehensive evaluation of two
complementary stent systems for the successful resolution of symptomatic
Dr. Faries and Dr. Rundback served as Co-Principal Investigators for both the
DURABILITY Iliac and VISIBILITY Iliac studies.
About the Covidien EverFlex and GPS Self-Expanding Stents
Part of Covidien’s extensive stent portfolio, the EverFlex self-expanding
stent system and the Protégé GPS self-expanding nitinol stent and delivery
technology offer a distinctive design that provides a unique combination of
flexibility, strength and precision needed to maintain vessel patency while
minimizing fractures. These stents offer a robust size matrix, enabling
physicians to treat a broad range of patient anatomies.
About the Covidien Visi-Pro Balloon Expandable Stent
The Visi-Pro balloon expandable stent is Covidien’s best-selling balloon
expandable stent system. In the U.S., Visi-Pro is the only 0.035” balloon
expandable stent that offers radiopaque tantalum GPS markers on the distal and
proximal ends of the stent, enhancing visualization both during and after
Covidien is a leading global healthcare products company that creates
innovative medical solutions for better patient outcomes and delivers value
through clinical leadership and excellence. Covidien manufactures, distributes
and services a diverse range of industry-leading product lines in three
segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2012
revenue of $11.9 billion, Covidien has 43,000 employees worldwide in 70
countries, and its products are sold in over 140 countries. Please visit
www.covidien.com to learn more about our business.
1. Hirsch AT, Criqui MH, Treat-Jacobson D, et al. Peripheral arterial disease
detection, awareness, and treatment in primary care. JAMA:The Journal of the
American Medical Association. Sep 19 2001;286(11):1317-1324.
David T. Young, 508-452-1644
Manager, External Communications
Bruce Farmer, 508-452-4372
Coleman Lannum, CFA, 508-452-4343
Todd Carpenter, 508-452-4363
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