EverFlex™ Self-Expanding Stent Approved for Superficial Femoral and
Proximal Popliteal Artery
MANSFIELD, Mass.--(BUSINESS WIRE)--Mar. 7, 2012--
(NYSE: COV), a leading global provider of healthcare products, today
announced that the U.S. Food and Drug Administration (FDA) has approved
Self-Expanding Peripheral Stent System for use in the
superficial femoral artery (SFA) and/or the proximal popliteal artery
(PPA). The EverFlex System, which has been approved for peripheral
indication in international markets since 2006, is now available in the
United States, including a 200 mm stent length.
The FDA has approved Covidien's EverFlex™ Self-Expanding Peripheral Stent System and is now available in the United States - including a 200 mm stent length. (Photo: Business Wire)
The clinical data supporting the FDA approval of the EverFlex System for
use in the peripheral vasculature was obtained through the DURABILITY II
Investigational Device Exemption trial that enrolled patients at
clinical sites within the U.S. and Europe. DURABILITY II is the first
clinical study to evaluate lesions up to 18 cm and to specifically test
the performance of a single long, up to 200 mm stent, in the SFA and
PPA. Specifically, the study results show no major adverse events at 30
days and a low one-year stent fracture rate of 0.4 percent.
Additionally, 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.
“DURABILITY II is a landmark trial intended to study the patency and
fracture resistance of placing a single nitinol stent in the superficial
femoral artery. It provided the clinical evidence necessary to
demonstrate that you can successfully treat long, complex lesions in the
SFA with the EverFlex Self-Expanding Peripheral Stent,” said Dr. Krishna
Rocha-Singh, MD, Director, Prairie Vascular Institute, Springfield,
Illinois, and co-national principal investigator of DURABILITY II.
Until now, physicians often addressed longer lesions by overlapping
multiple stents. Overlapping stents have a higher propensity to
fracture, thereby increasing the potential for restenosis to occur.
Being able to place one long stent, versus multiple shorter stents, may
lead to better long term clinical performance.
“The DURABILITY II findings demonstrate the safety and effectiveness of
our EverFlex stents,” said Mark A. Turco, MD, Chief Medical Officer,
Vascular Therapies, Covidien. “Having an indication in the SFA - as well
as a 200 mm stent - is imperative when treating Peripheral Arterial
One of the most common vascular diseases, 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.
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.
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Rachel Bloom-Baglin, 508-261-6651
Lannum, CFA, 508-452-4343