Abbott Announces FDA Approval of Its Supera® Stent to Treat People with
Peripheral Artery Disease
Supera Stent Addresses Growing Need in the U.S. to Treat People with Blocked
Blood Vessels and Restore Blood Flow in the Upper Leg
ABBOTT PARK, Ill., March 28, 2014
ABBOTT PARK, Ill., March 28, 2014 /PRNewswire/ -- Abbott today announced that
its Supera^® Peripheral Stent System has received U.S. Food and Drug
Administration (FDA) approval to treat people with blocked blood vessels in
the upper leg caused by peripheral artery disease (PAD). PAD occurs when fat
and cholesterol buildup causes arteries outside of the heart to narrow, which
reduces blood flow to parts of the body, most commonly the legs. The disease
affects 12 to 20 percent of Americans age 65 or older and can cause leg pain,
in addition to increasing the risk of heart attack or stroke.^1
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The Supera stent, which mimics rather than resists the artery's natural
movement, is an important advancement for many PAD patients, helping to ease
their leg pain while walking.^2 Its unique, proprietary interwoven wire
technology restores blood flow to the treated area, while offering strength
and flexibility. Specifically, the Supera stent is now approved to treat
blockages in the superficial femoral artery (SFA), a blood vessel in the
thigh, and the proximal popliteal artery (PPA), a blood vessel above the knee.
Compared to other nitinol stents used to treat blocked blood vessels in the
upper leg, the Supera stent is more flexible, stronger and resistant to kinks
or fracture under vigorous movement.^3 These features are particularly
important when treating vessels in the leg, where frequent movement occurs
with daily activities, such as walking, sitting and standing.
"Doctors are increasingly identifying peripheral artery disease as a major
cause of leg pain, which can limit people's ability to live a healthy
lifestyle," said Kenneth Rosenfield, M.D., section head of Vascular Medicine
and Intervention at Massachusetts General Hospital and the principal
investigator of the SUPERB clinical trial, which evaluated the Supera stent.
"Treatment with the Supera stent, as shown by the results of the SUPERB study,
is very effective in easing leg pain, enabling the majority of patients to
resume their activities."
Data from the SUPERB clinical trial, which was used to support FDA approval of
the Supera stent, have shown the Supera stent to be highly effective in
opening up blocked blood vessels in the upper leg, even in difficult cases,
and results have been shown to last over time.^2 In addition, during the first
year after treatment with the Supera stent there were no stent fractures, and
at two years there was a very low stent fracture rate of 0.5 percent.^2 Stent
fractures are a known risk of treatment with traditional metallic stents in
the leg due to the frequency and type of movement in this part of the body.
"FDA approval of the Supera stent provides an additional treatment option that
can make a positive impact on the lives of people suffering from peripheral
artery disease," said Chuck Foltz, senior vice president, vascular, Abbott.
"FDA approval of the Supera stent gives Abbott rapid entry into one of the
fastest-growing segments of the peripheral stent market, providing Abbott with
one of the most comprehensive and competitive peripheral technology portfolios
in the industry."
Abbott expanded its product portfolio with the Supera stent through the
acquisition of IDEVTechnologies in August 2013. The Supera stent has CEMark
in Europe for treating blocked blood vessels caused by PAD.
About the Supera ^ Peripheral Stent System
The Supera Peripheral Stent System is indicated to improve luminal diameter in
the treatment of patients with symptomatic de novo or restenotic native
lesions or occlusions of the superficial femoral artery (SFA) and/or proximal
popliteal artery with a reference vessel diameter of 4.0-6.5 mm, and lesion
lengths up to 140 mm.
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About Abbott Vascular
Abbott Vascular is the world's leader in drug-eluting stents. Abbott Vascular
has an industry-leading pipeline and a comprehensive portfolio of
market-leading products for cardiac and vascular care, including products for
coronary artery disease, vessel closure, endovascular disease and structural
Abbott is a global healthcare company devoted to improving life through the
development of products and technologies that span the breadth of healthcare.
With a portfolio of leading, science-based offerings in diagnostics, medical
devices, nutritionals and branded generic pharmaceuticals, Abbott serves
people in more than 150 countries and employs approximately 69,000 people.
^1 Roger VL, Go AS, Lloyd-Jones DM, et al. Heart Disease and Stroke
Statistics—2011 Update: A report from the American Heart Association.
Circulation 2011; http://circ.ahajournals.org/content/123/4/e18.
^2 Supera® Peripheral Stent System Instructions for Use. Data on file at
^3 Data on file at Abbott Vascular.
Contact: Media: Steve Kelly (408) 845-3427; Gayathri Badrinath, (408)
845-8292; Financial: Tina Ventura, (847) 935-9390
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