FDA Approves Abbott's XIENCE(TM) V Drug Eluting Stent

Abbott Park, Illinois (ots/PRNewswire) -

- XIENCE V, Only Drug Eluting Stent to Demonstrate Superiority
Over Market-Leading Stent in Clinical Trials, Now Available in United
States for Treatment of Coronary Artery Disease

Abbott today announced that the U.S. Food and Drug Administration
(FDA) approved the XIENCE(TM) V Everolimus Eluting Coronary Stent
System for the treatment of coronary artery disease. XIENCE V is the
only drug eluting stent to have demonstrated superiority over Boston
Scientific's TAXUS(R) paclitaxel-eluting coronary stent system in two
randomized head-to-head clinical trials. XIENCE V will be launched in
the United States immediately.

"XIENCE V represents an important treatment advance for the
estimated 13 million people in the United States suffering from
coronary artery disease, and we believe XIENCE V will quickly become
the new standard for drug eluting stents given its outstanding
clinical results," said John M. Capek, Ph.D., executive vice
president, Medical Devices, Abbott. "Physicians in the United States
have been waiting for years to treat their patients with a technology
that delivers on the promise of drug eluting stents through both ease
of use and excellent clinical performance, and XIENCE V is that
technology."

The XIENCE V drug coated stent is used to treat coronary artery
disease by propping open a narrowed or blocked artery and releasing
the drug, everolimus, in a controlled manner to prevent the artery
from becoming blocked again following a stent procedure. Coronary
artery disease occurs when plaque build-up narrows the arteries and
reduces blood flow to the heart, which can lead to chest pain or a
heart attack.

"XIENCE V was designed to improve safety and efficacy compared to
earlier generation stents. The long-term clinical data from two
studies performed in both the United States and Europe have now
confirmed that XIENCE V is a true next-generation drug eluting stent
with clinically important benefits for patients," said Gregg W.
Stone, M.D., Columbia University Medical Center; chairman,
Cardiovascular Research Foundation, New York; and principal
investigator of the SPIRIT III U.S. pivotal clinical trial for XIENCE
V.

Clinical Data Supporting XIENCE V

The robust clinical program for XIENCE V includes long-term data
from a total of 1,362 patients enrolled in the SPIRIT FIRST, SPIRIT
II and SPIRIT III trials, as well as continued access and
post-approval programs that will enroll more than 14,000 XIENCE V
patients.

The FDA approved XIENCE V based, in large part, on superior
results from the 1,002 patient SPIRIT III U.S. pivotal clinical
trial, in which XIENCE V demonstrated statistical superiority to
TAXUS on the study's primary endpoint of in-segment late loss (vessel
renarrowing) at eight months, with a statistically significant 50
percent reduction (mean, 0.14 mm for XIENCE V vs. 0.28 mm for TAXUS).
XIENCE V also demonstrated statistical non-inferiority to TAXUS in
the co-primary endpoint of target vessel failure (TVF, cardiac events
related to the stented vessel) at nine months, with an observed 20
percent reduction (7.2 percent for XIENCE V vs. 9.0 percent for
TAXUS). TVF is a composite clinical measure of safety and efficacy
outcomes defined as cardiac death, heart attack (myocardial
infarction or MI) or target vessel revascularization (TVR).

In May 2008, Abbott presented two-year data from the SPIRIT III
trial demonstrating that XIENCE V continues to deliver positive
clinical benefits for patients. At two years, the XIENCE V
demonstrated the following key results:

-- A 45 percent reduction in the risk of major adverse cardiac
events (MACE) compared to TAXUS (7.3 percent for XIENCE V vs. 12.8
percent for TAXUS, p-value=0.004)*. MACE is an important composite
clinical measure of safety and efficacy outcomes for patients,
defined as cardiac death, heart attack (MI) or ischemia-driven target
lesion revascularization (TLR, repeat procedures driven by lack of
blood supply).

-- A 32 percent reduction in the risk of TVF compared to TAXUS
(10.7 percent for XIENCE V vs. 15.4 percent for TAXUS,
p-value=0.04)*.

-- Low rates of stent thrombosis between one and two years,
defined as very late stent thrombosis, per Academic Research
Consortium (ARC) definition of definite/probable stent thrombosis
(0.3 percent for XIENCE V and 1.0 percent for TAXUS) and per the
SPIRIT III protocol (0.2 percent for XIENCE V and 1.0 percent for
TAXUS). The ARC definition of late stent thrombosis was developed to
eliminate variability in the definitions across various drug eluting
stent trials.

"Today's approval of XIENCE V is a reflection of Abbott's ongoing
commitment to bring innovation-driven, leading-edge medical
technologies to the people who need them," added Capek. "With one of
the largest, most seasoned vascular sales forces in the United States
and with the ability to supply more than half the worldwide market,
we will begin shipping units of XIENCE V immediately to meet
physician demand for this much awaited, next-generation technology."

More About XIENCE V

XIENCE V is built upon Abbott's market-leading bare metal stent,
the MULTI-LINK VISION(R) Coronary Stent System. The VISION platform
is designed to facilitate ease of delivery, making it easier for
physicians to maneuver the stent and treat the diseased portion of
the artery.

The XIENCE V drug coated stent will be available on both
over-the-wire (OTW) and rapid exchange (RX) delivery systems. Rapid
exchange is the most widely used type of delivery system because it
provides physicians additional flexibility to work as single
operators during stent procedures.

XIENCE V was launched in Europe and other international markets
in October 2006. XIENCE V is an investigational device in Japan and
is currently under review for approval by Japan's Ministry of Health,
Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices
Agency (PMDA).

Abbott also supplies a private-label version of XIENCE V to
Boston Scientific called the PROMUS(TM) Everolimus-Eluting Coronary
Stent System. PROMUS is designed and manufactured by Abbott and
supplied to Boston Scientific as part of a distribution agreement
between the two companies.

Everolimus, developed by Novartis Pharma AG, is a proliferation
signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis
for use on its drug eluting stents. Everolimus has been shown to
inhibit in-stent neointimal growth in the coronary vessels following
stent implantation, due to its antiproliferative properties.

Additional information about XIENCE V, including important safety
and effectiveness information, is available online at
http://www.xiencev.com.

About Abbott Vascular

Abbott Vascular, a division of Abbott, is one of the world's
leading vascular care businesses. Abbott Vascular is uniquely focused
on advancing the treatment of vascular disease and improving patient
care by combining the latest medical device innovations with
world-class pharmaceuticals, investing in research and development
and advancing medicine through training and education. Headquartered
in Northern California, Abbott Vascular offers a comprehensive
portfolio of vessel closure, endovascular and coronary products.

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 more than 68,000 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 http://www.abbott.com.

*Event rates are based on Kaplan-Meier estimates; p-values are
for descriptive purposes only.

EDITORS NOTE: Additional background information, including
broadcast-quality video, animation and images, are available to
members of the media through the XIENCE V media kit at
http://www.xiencemediakit.com.

Web site: http://www.abbott.com
http://www.xiencev.com

ots Originaltext: Abbott Laboratories
Im Internet recherchierbar: http://www.presseportal.de

Contact:
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