MIAMI--(BUSINESS WIRE)--Jan. 24, 2012--
Covidien (NYSE: COV), a leading global provider of healthcare products,
today announced that one-year results on the use of its EverFlex™ stent
for superficial femoral artery stenting were presented here during the International
Symposium on Endovascular Therapy (ISET) Conference.
Presenting the data was co-National Principal Investigator Jon
Matsumura, MD, of the Division of Vascular Surgery, University of
Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
Named DURABILITY II, the clinical study enrolled 287 subjects at 44
investigational sites in both the U.S. and Europe. The study evaluated
the safety and efficacy of a single self-expanding stent up to 20 cm in
length. The study focused on patients with atherosclerotic disease of
the superficial femoral artery and superficial femoral and proximal
One of the most common vascular diseases, peripheral arterial disease
(P.A.D.) occurs when leg arteries become narrowed or blocked by plaque.
These blockages can result in severe pain, limited physical mobility and
non-healing leg ulcers. According to the American Heart Association,
approximately 10 million people in the U.S. suffer from P.A.D.
DURABILITY II enrolled patients with lesions up to 18 cm in length; its
primary endpoints were 30-day major adverse event rate and primary
patency at one year, compared to performance goals published by VIVA
Physicians Inc. (VPI). The mean age of subjects was 68 years, with 66
percent male. Prominent comorbidities included hypertension (88
percent), hyperlipidemia (86 percent), and diabetes (43 percent). The
mean lesion length as measured by core laboratory was 89.1 mm, while the
mean normal-to-normal lesion length measured by sites was 109.6 mm.
No major adverse events occurred at 30 days. Primary patency at one year
was 67.7 percent when analyzed by simple proportions of patients patent;
using Kaplan-Meier time-to-event analysis, it was 77.2 percent. The
results met predetermined VPI performance goals for safety and
effectiveness. The one-year stent fracture rate was 0.4 percent.
“In another new chapter of minimally invasive treatment of P.A.D.,
DURABILITY II evaluated a novel longer stent system that offers the
option of single stent treatment of extensive symptomatic femoral artery
disease,” said Dr. Matsumura. “The results are impressive.”
The results from this Investigational Device Exemption study are
included in the pre-market approval application of the EverFlex stent
system, which is currently under review by the U.S. Food and Drug
The EverFlex stent system is designed to enable physicians to treat long
lesions in P.A.D. patients with a single stent, thereby minimizing the
occurrence of stent fractures. Previous studies have reported stent
fracture in overlapped nitinol stents. The intent is to eliminate the
need for overlapping two short stents by using one long stent in order
to reduce the possibility of stent fracture.
“DURABILITY II is part of a series of clinical trials focused on primary
stenting as an important option in the treatment of P.A.D.,” said Stacy
Enxing Seng, President, Vascular Therapies, Covidien. “Our
significant investment in these studies demonstrates Covidien’s ongoing
commitment to evidence-based medicine and clinically relevant
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 2011 revenue of $11.6 billion, Covidien has 41,000
employees worldwide in more than 65 countries, and its products are sold
in over 140 countries. Please visit www.covidien.com
to learn more about our business.
Rachel Bloom-Baglin, 508-261-6651
Lannum, CFA, 508-452-4343