Abbott’s Market-Leading XIENCE V(R) Shows Increasing Clinical Advantages Over TAXUS(R) Express2(TM)/TAXUS(R) Liberte(TM) Between Two and Three Years

By Prne, Gaea News Network
Saturday, March 28, 2009

ORLANDO, Florida - In SPIRIT II Trial, XIENCE V Drug Eluting Stent Demonstrates Clinically
Meaningful Reductions Compared to TAXUS in Key Safety Endpoints, Including an
88 Percent Reduction in the Risk of Cardiac Death at Three Years

Long-term data presented today from Abbott’s (NYSE: ABT) SPIRIT II
clinical trial demonstrated that the clinical advantages of the XIENCE V(R)
Everolimus Eluting Coronary Stent System continued to increase between two
and three years compared to the TAXUS(R) Express2(TM) Paclitaxel-Eluting
Coronary Stent System / TAXUS(R) Liberte(TM) Paclitaxel-Eluting Coronary
Stent System (TAXUS). Both TAXUS Express2 (73 percent of lesions) and TAXUS
Liberte (27 percent of lesions) were used as controls in the SPIRIT II trial.
The data also showed that patients treated with XIENCE V continue to
experience fewer heart attacks, deaths or repeat procedures at the target
lesion compared to patients treated with TAXUS out to three years. The
results from the SPIRIT II trial were presented during the i2 Summit at the
American College of Cardiology’s 58th annual scientific session in Orlando,
Fla.

Between two and three years, Abbott’s market-leading XIENCE V maintained
a low cardiac death rate of 0.5 percent, while the observed cardiac death
rate for TAXUS more than tripled during the same time period (1.3 percent at
two years vs. 4.2 percent at three years)*. Similarly, XIENCE V maintained a
low, single-digit rate of major adverse cardiac events (MACE) between two and
three years (6.4 percent at two years vs. 6.4 percent at three years), while
the observed MACE rate with TAXUS increased approximately 40 percent between
two and three years (10.5 percent at two years vs. 14.9 percent at three
years)*. MACE is an important composite clinical measure of safety and
efficacy outcomes for patients, defined as cardiac death, heart attack
(myocardial infarction or MI), or ischemia-driven target lesion
revascularization (ID-TLR driven by lack of blood supply).

In addition, the SPIRIT II results demonstrated that XIENCE V continues
to outperform TAXUS, with XIENCE V showing continued clinical benefits at
three years, including an 88 percent reduction in the risk of cardiac death
and a 57 percent reduction in the risk of MACE.

“In the clinical outcomes that matter most, such as heart attack, repeat
procedure at the target lesion or death, XIENCE V demonstrated a consistent
reduction compared to TAXUS out to three years,” said Patrick W. Serruys,
M.D., Ph.D., professor of Interventional Cardiology at Thoraxcentre, Erasmus
University Hospital, Rotterdam, the Netherlands, and principal investigator
of the SPIRIT II clinical trial. “What’s even more impressive is that the
clinical differences between XIENCE V and TAXUS continue to widen between two
and three years, confirming the long-term safety and efficacy of XIENCE V.”

In the 300-patient SPIRIT II trial, XIENCE V demonstrated the following
key results at three years:

– An 88 percent reduction in the risk of cardiac death compared to TAXUS
(0.5 percent for XIENCE V vs. 4.2 percent for TAXUS, p-value=0.024)*.
— A 57 percent reduction in the risk of MACE compared to TAXUS (6.4
percent for XIENCE V vs. 14.9 percent for TAXUS, p-value=0.029)*.
— An observed 52 percent reduction in the risk of heart attacks (MI)
compared to TAXUS (3.3 percent for XIENCE V vs. 6.8 percent for TAXUS,
p-value=0.20)*.
— An observed 56 percent reduction in the risk of ID-TLR compared to
TAXUS (4.2 percent for XIENCE V vs. 9.4 percent for TAXUS,
p-value=0.092)*.
— No stent thrombosis between two and three years with XIENCE V, and a
low rate of stent thrombosis from zero to three years, per Academic
Research Consortium (ARC) definition of definite/probable stent
thrombosis (0.9 percent for XIENCE V and 2.8 percent for TAXUS,
p-value=0.27)*. The ARC definitions of stent thrombosis were developed
to eliminate variability in the definitions across various drug
eluting stent trials.

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

“The data from the SPIRIT family of trials continue to prove that XIENCE
V is an excellent option for patients. Physicians have embraced this
technology, as demonstrated by the market-leading position of XIENCE V around
the world,” said John Capek, Ph.D., executive vice president, Medical
Devices, Abbott. “Our next-generation drug eluting stent in development,
XIENCE PRIME, builds upon the outstanding body of clinical evidence from the
SPIRIT family of clinical trials, while the new stent design and its delivery
system build upon the excellent performance of the VISION cobalt chromium
platform, improving deliverability and helping physicians treat difficult
lesions.”

XIENCE V is the market-leading drug eluting stent platform, with 50
percent share in the United States, and market-leading share around the
world.

Abbott’s next-generation XIENCE PRIME(TM) Everolimus Eluting Coronary
Stent System utilizes the same drug and polymer as Abbott’s market-leading
XIENCE V stent and builds upon the proven design of the MULTI-LINK(R) family
of stents. XIENCE PRIME features a new stent design and delivery system that
are designed to make it more flexible for improved deliverability. Abbott
plans to make XIENCE PRIME available in an expanded size matrix with lengths
up to 38 mm. The company expects to launch XIENCE PRIME in Europe later this
year.

About the SPIRIT II Trial

SPIRIT II is a prospective, multi-center, randomized, single-blind,
controlled clinical trial comparing XIENCE V to TAXUS in 300 patients (223
XIENCE V patients, 77 TAXUS patients) with either one or two de novo native
coronary artery lesions. Patients from Europe, India and New Zealand were
enrolled in the trial between July 5, 2005, and Nov.15, 2005.

The primary endpoint of the SPIRIT II trial was in-stent late loss at six
months, wherein XIENCE V demonstrated superiority to TAXUS with a
statistically significant 69 percent reduction in late loss (mean, 0.11 mm
for XIENCE V vs. 0.36 mm for TAXUS). In-stent late loss is a measure of
vessel re-narrowing.

About XIENCE V

XIENCE V 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.

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 stent is 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 approved by the U.S. Food and Drug Administration and
launched in July 2008, and was launched in Europe and other international
markets in October 2006. XIENCE V is an investigational device in Japan and
is currently under review by Japan’s Ministry of Health, Labour and Welfare
and the Pharmaceuticals and Medical Devices Agency.

Abbott also supplies a private-label version of XIENCE V to Boston
Scientific called the PROMUS(R) 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
anti-proliferative properties.

Additional information about XIENCE V, including important safety and
effectiveness information, is available online at 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 72,000 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.

Source: Abbott

Media, Jonathon Hamilton, +1-408-624-0314, or Jennie Kim, +1-408-332-4176, or Financial, Tina Ventura, +1-847-935-9390, all of Abbott

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