The New England Journal of Medicine Publishes Results of Landmark CREST Study, Showing Similar Positive Outcomes for Abbott's Carotid Stent System and Surgery

By Abbott, PRNE
Tuesday, May 25, 2010

Company Plans to File Application by End of Year Seeking an Expanded Indication to Treat Standard-Surgical-Risk Patient Population

ABBOTT PARK, Illinois, May 26, 2010 - Data from the CREST (Carotid Revascularization Endarterectomy vs.
Stenting Trial) study were published today in The New England Journal of
Medicine. In this trial, stenting and surgery had similar initial safety and
longer-term outcomes for symptomatic and asymptomatic men and women. Adverse
event rates of death, stroke and heart attack were also similar for both
therapies. Abbott's ACCULINK(R) Carotid Stent System and ACCUNET(R) Embolic
Protection System were used in the study, which was sponsored by the National
Institute of Neurological Disorders and Stroke (NINDS), part of the National
Institutes of Health (NIH), and partially funded by Abbott.

"As the worldwide market leader in the interventional treatment of
carotid artery disease, we are proud of our long-standing commitment to
expanding treatment options for patients and to advancing clinical evidence
in the field, including our support of the landmark CREST study," said Robert
Hance
, senior vice president, vascular, Abbott. "Based on the strength of the
CREST data, we plan to file an application in the U.S. by the end of this
year seeking an expanded indication for the ACCULINK Carotid Stent System to
treat patients with carotid artery disease who are at standard risk for
surgery."

All carotid stent systems in the United States are currently indicated
only for patients who are considered to be at high risk for surgical
treatment due to anatomical factors, age or other considerations. The
majority of patients with carotid artery disease are not part of this
high-risk group, and therefore are not within the current U.S. Food and Drug
Administration (FDA) indications for carotid stenting.

Abbott will submit the results of a pre-agreed-upon analysis of the CREST
data to the FDA in an application seeking an expanded indication for the
ACCULINK Carotid Stent System as a treatment option for patients at standard
surgical risk (those patients not considered to be at high risk for surgery).
Abbott will seek Medicare coverage for standard-risk patients if the FDA
approves the treatment for this broader patient group.

"As a neurosurgeon who has performed both carotid surgeries and carotid
stenting procedures, I am pleased to see that carotid stenting and carotid
surgery had comparable outcomes for a majority of standard-risk patients in
this trial," said L. Nelson "Nick" Hopkins III, M.D., chairman of
Neurosurgery, professor of Radiology, and director of the Toshiba Stroke
Research Center at the University at Buffalo, State University of New York.
"Both therapies met the American Heart Association guidelines for patients
with carotid narrowing. Experience, training and patient selection will
continue to be of paramount importance in determining success for both
treatments."

CREST demonstrated results consistent with long-standing American Heart
Association (AHA) guidelines for outcomes in patients with a severe carotid
stenosis. These guidelines state that rates of death and stroke for carotid
artery surgery within 30 days of the procedure be less than 3 percent for
asymptomatic patients and less than 6 percent for symptomatic patients.

In addition to CREST, Abbott is currently enrolling patients in ACT I -
an additional randomized clinical trial of patients at standard risk for
surgical treatment, which will include up to 1,658 asymptomatic patients
under the age of 80. This multi-center study compares carotid surgery to
Abbott's second carotid stent and embolic protection system - the Xact(R)
Rapid Exchange Carotid Stent System and the Emboshield family of embolic
protection systems.

Abbott is the only company with two distinct carotid stent and embolic
protection systems approved by the FDA and on the market in the United
States
. Abbott also has the most comprehensive clinical trial program
studying the benefits of carotid artery stenting. To date, approximately
25,000 patients have been enrolled in nine clinical trials evaluating
Abbott's carotid stent systems.

Since the first carotid stent approval in Europe in 1999, more than
100,000 patients have been treated with Abbott's carotid stents and embolic
protection systems throughout the world.

For more information about Abbott's carotid stent and embolic protection
systems, please visit www.carotidmediakit.com.

About the CREST Study

CREST is a randomized, multi-center clinical trial comparing outcomes of
carotid artery stenting and carotid surgery in symptomatic and asymptomatic
patients with carotid artery disease.

In the study, stenting and surgery had similar initial safety and
longer-term outcomes for symptomatic and asymptomatic men and women. The
study showed equivalent low rates of adverse events for either procedure in
the 2,502 patients studied, with 6.8 percent of surgery patients and 7.2
percent of stenting patients experiencing a primary endpoint of death, stroke
or heart attack event in the periprocedural period (during the procedure and
within approximately 30 days thereafter) and ipsilateral strokes up to four
years after the procedure (mean follow-up of 2.5 years). In the
periprocedural period, 5.2 percent of surgery patients and 4.5 percent of
stenting patients experienced any of these adverse events, with a rate of
stroke of 2.3 percent in the surgical patients and 4.1 percent in the
stenting group, and a rate of heart attack of 2.3 percent in the surgical
group and 1.1 percent in the stenting group. After the periprocedural period,
the incidence of ipsilateral stroke was similar for stenting (2.0 percent)
and surgery (2.4 percent).

The rate of cranial nerve palsy during the periprocedural period was 4.7
percent for the surgical group and 0.3 percent for the stenting group
(representing crossover stenting patients who also underwent the surgical
procedure). Cranial nerve palsy refers to a temporary injury of the nerves
that run close to the carotid artery, potentially causing difficulty with
speaking, swallowing and facial expressions. It is not a complication of
stenting.

Treatments for Carotid Artery Disease

Carotid artery disease involves the buildup of plaque in one or both
carotid arteries in the neck. The carotid arteries supply vital oxygen and
glucose-rich 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 - which
currently is approved in the United States for high-risk patients only -
carotid surgery, known as carotid endarterectomy, or medical therapy.

The traditional surgical treatment for carotid artery disease usually
entails 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 and remove particles of plaque that might be
dislodged during the procedure, which could potentially lead to stroke and
other complications.

About Stroke and Carotid Artery Disease

Stroke is the third leading cause of death in the United States and the
number one cause of disability in adults, according to the American Heart
Association. Strokes can be caused by carotid artery disease. An ischemic
stroke, the most common type, can occur when carotid arteries become 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 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 dies of stroke.(1)

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 (NYSE: ABT) 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 approximately 83,000 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 www.abbott.com.

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

Media, Jonathon Hamilton, +1-408-624-0314 or Jennie Kim, +1-408-332-4176; or Financial, Larry Peepo, +1-847-935-6722 or Tina Ventura, +1-847-935-9390 all for Abbott

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