Abbott Receives FDA Approval to Expand Use of the RX ACCULINK(R) Carotid Stent System to Patients at Standard Surgical Risk

By Abbott, PRNE
Thursday, May 5, 2011

Expanded Indication Supported by Results from the CREST Trial, Which Demonstrated Similar Safety and Efficacy for Stenting and Surgery

ABBOTT PARK, Illinois, May 6, 2011 - Abbott (NYSE: ABT) today announced that the U.S. Food and Drug
Administration (FDA) approved the RX ACCULINK(R) Carotid Stent System for the
treatment of patients with carotid artery disease who are at standard risk of
adverse events from carotid endarterectomy (surgery). RX ACCULINK was
previously indicated for patients at high risk of adverse events from
surgery. This expanded indication is supported by the results of the CREST
(Carotid Revascularization Endarterectomy vs. Stenting Trial) study. RX
ACCULINK, used with the RX ACCUNET(R) Embolic Protection System, represents
an important option for standard-risk patients for the treatment of carotid
artery disease.

"The CREST data demonstrated that carotid artery stenting is a safe,
effective and minimally invasive treatment for standard-risk patients with
carotid artery disease," said L. N. Hopkins, M.D., Professor and Chairman,
Department of Neurosurgery, and Professor of Radiology, State University of
New York at Buffalo
. "With this broader indication, the RX ACCULINK Carotid
Stent System will become an important option for physicians as they determine
the most appropriate treatment approach for their patients."

As part of its submission for an expanded indication, Abbott submitted
the results of the CREST study, which is the largest prospective study
conducted to date comparing carotid artery stenting to surgery. CREST was
sponsored by the National Institute of Neurological Disorders and Stroke
(NINDS), part of the National Institutes of Health (NIH), and was partially
funded by Abbott. The trial demonstrated that carotid artery stenting and
carotid surgery had similar safety and long-term outcomes for standard-risk
patients with symptomatic and asymptomatic carotid artery disease.

"FDA approval of the RX ACCULINK Carotid Stent System for patients at
standard risk of surgery has the potential to significantly impact the
treatment of patients with carotid artery disease," said Charles A. Simonton,
M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief
medical officer, Abbott Vascular. "More than 60 percent of U.S. patients with
carotid artery disease are at standard surgical risk, many of whom require a
procedure to open the narrowed arteries that lead to the brain. This expanded
indication for Abbott's RX ACCULINK provides these patients with an
additional treatment option."

Abbott intends to seek expanded Medicare coverage for carotid stenting
based on the CREST trial results. In addition, the company plans to initiate
a post-approval study of the RX ACCULINK Carotid Stent System in patients at
standard surgical risk later this year. The study is planned to assess
clinical outcomes at 30 days and annually for three years.

About RX ACCULINK Carotid Stent System

The RX ACCULINK Carotid Stent System, used in conjunction with the RX
ACCUNET Embolic Protection System, is indicated for the treatment of patients
at high risk and standard risk of adverse events from carotid endarterectomy
who require carotid revascularization (a procedure to restore blood flow) and
meet certain criteria. Additional information about the RX ACCULINK Carotid
Stent System, including important safety information, is available online at

About Stroke and Carotid Artery Disease

Stroke is the third leading cause of death in the U.S. and the number one
cause of disability in adults, according to the American Heart Association.
An ischemic stroke, the most common type, can occur when the carotid artery
becomes narrowed and when small particles of atherosclerotic plaque become
dislodged from the diseased artery wall. This embolic material can travel
through the bloodstream and block blood vessels in the brain. More than
795,000 Americans will have new (610,000) or recurrent (185,000) strokes each
year. On average, every four minutes someone in the U.S. dies of stroke.(1)

Carotid artery disease is the leading cause of stroke in the U.S., with
more than 60 percent of all stroke occurrences known to be linked to carotid
artery disease.(2) Carotid artery disease involves the buildup of plaque in
one or both carotid arteries in the neck. The carotid arteries supply oxygen
and blood to the parts of the brain where thinking, speech, personality, and
sensory and motor functions reside.

Patients with carotid artery disease have three treatment options:
carotid artery stenting, carotid surgery (known as carotid endarterectomy) or
medical therapy. The traditional surgical treatment for carotid artery
disease usually requires general anesthesia and involves an incision in the
patient's neck and artery to remove plaque from inside the vessel wall. In
contrast, during a carotid stenting procedure, an embolic protection system
is positioned in the carotid artery and a stent is deployed using a catheter
inserted into a small puncture in the patient's groin. The patient usually
remains conscious while the stent is implanted at the site of the blockage.
The embolic protection system is designed to capture particles of plaque that
might be dislodged during the procedure, which could potentially lead to
stroke and other complications.

About Abbott Vascular

Abbott Vascular is a global leader in cardiac and vascular care with
market-leading products and an industry-leading pipeline. Abbott Vascular
offers a comprehensive cardiac and vascular devices portfolio, including
products for coronary artery disease, vessel closure, endovascular disease,
and structural heart disease.

About Abbott

Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The
company employs nearly 90,000 people and markets its products in more than
130 countries.

Abbott's news releases and other information are available on the
company's Web site at

(1) Circulation "Heart Disease and Stroke Statistics 2010 Update. A
Report from the American Heart Association." January 26, 2010

(2) New Technology Brief "Carotid Stenting". A Report from the Health
Care Advisory Board. 2006.

Media, Jonathon Hamilton, +1-408-624-0314, or Jean Suzuki, +1-408-845-3887, or Financial, Larry Peepo, +1-847-935-6722, or Tina Ventura, +1-847-935-9390, all of Abbott

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