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Abbott Announces FDA Approval and U.S. Launch of Next-Generation XIENCE Xpedition Drug Eluting Stent System

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Thu Jan 3, 2013 8:30am EST

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-      Enhanced Deliverability with New Drug Eluting Stent Delivery System
ABBOTT PARK, Ill.,  Jan. 3, 2013  /PRNewswire/ -- Abbott (NYSE: ABT) today
announced that the XIENCE Xpedition™  Everolimus Eluting Coronary Stent System
received U.S. Food and Drug Administration (FDA) approval and is launching
immediately in  the United States, providing physicians with a next-generation
technology with the largest size matrix in the U.S. market. XIENCE Xpedition
features a new stent delivery system designed to optimize deliverability,
particularly in challenging coronary anatomies.  

Samin K. Sharma, M.D., director of Clinical and Interventional Cardiology, dean
of International Clinical Affiliations, and president of the Mount Sinai Heart
Network at Mount Sinai Medical Center,  New York, was the first physician to
implant a patient with XIENCE Xpedition in  the United States.  

"XIENCE Xpedition represents a powerful combination of deliverability, strong
clinical data and broad availability of meaningful sizes - three factors that
make this product well-suited to treat a wide range of patients," said Dr.
Sharma. "The impact of the changes to the stent delivery system is particularly
notable in patients with complex coronary anatomy. For these patients,
physicians have a new technology to reach the blockage and restore blood flow
with ease and confidence."

Abbott's XIENCE drug eluting stents, including the newly approved XIENCE
Xpedition, are the first and only drug eluting stents in the U.S. market to be
proven safe for direct stenting. Direct stenting, a technique in which the stent
system is not preceded by another device (such as a balloon dilatation catheter)
to prepare the lesion, has the potential to save time and resources in the
catheterization laboratory. XIENCE Xpedition is supported by robust clinical
evidence from the XIENCE family of drug eluting stents, including data from more
than 45,000 patients across more than 100 studies, with long-term outcomes out
to five years. Data have consistently shown an excellent safety profile for the
XIENCE family of stents.  

"The launch of XIENCE Xpedition in  the United States  will advance Abbott's
worldwide market-leading position in drug eluting stents," said  John M. Capek,
Ph.D., executive vice president, Medical Devices, Abbott. "XIENCE Xpedition
leverages the strong clinical outcomes of XIENCE V and XIENCE PRIME while
providing important advantages in deliverability. With its redesigned stent
delivery system and a full matrix of sizes, XIENCE Xpedition provides physicians
with a comprehensive, trusted option to treat a broad range of patients with
coronary artery disease."  

XIENCE Xpedition will be available in the largest size matrix in the U.S.
market, with both rapid exchange (RX) and over-the-wire (OTW) configurations,
providing physicians with the most popular delivery platforms. XIENCE Xpedition
has diameters ranging from 2.25 mm to 4 mm, including a unique 3.25 mm diameter,
and lengths from 8 mm to 38 mm, for more accurate vessel sizing.

About the XIENCE Family of Drug Eluting Stents

XIENCE Xpedition is available in  the United States,  Europe, the  Middle East 
and parts of  Asia. XIENCE PRIME® and XIENCE V® are available in countries
throughout the world.

In  the United States, XIENCE Xpedition and XIENCE PRIME are indicated for
improving coronary artery luminal diameter in patients with symptomatic heart
disease due to  de novo  native coronary artery lesions (length ≤ 32 mm) with
reference vessel diameters of ≥ 2.25 mm to ≤ 4.25 mm. Additional information,
including important safety information, about XIENCE Xpedition is available at 
www.xiencestent.com  or 
http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/coronary_intervention/eIFU_Xience_Xpedition.pdf
 and for XIENCE PRIME at 
http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/coronary_intervention/eIFU_XIENCE_PRIME_XIENCE_PRIME_LL.pdf.
 

In  the United States, XIENCE V and XIENCE nano®  are indicated for improving
coronary luminal diameter in patients with symptomatic heart disease due to  de
novo  native coronary artery lesions (length ≤28 mm) with reference vessel
diameters of 2.25 mm to 4.25 mm. Additional information about XIENCE V and
XIENCE nano, including important safety information, is available at 
www.xiencestent.com  or 
http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/coronary_intervention/eIFU_XIENCE_V_XIENCE_nano.pdf.

Everolimus is an anti-proliferative drug used in Abbott's XIENCE coronary stent
systems. Everolimus was developed by Novartis Pharma AG and is licensed to
Abbott by Novartis for use on its drug eluting vascular devices. Everolimus has
been shown to inhibit in-stent neointimal growth in the coronary vessels
following stent or scaffold implantation.

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 heart disease.

About Abbott  

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 70,000 people.  

Visit Abbott at  www.abbott.com  and connect with us on Twitter at @AbbottNews.

SOURCE  Abbott


Media, Jonathon Hamilton, +1-408-845-3491; Financial, Tina Ventura,
+1-847-935-9390
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