Abbott Announces FDA Approval and U.S. Launch of Next-Generation XIENCE
Xpedition™ Drug Eluting Stent System
ABBOTT PARK, Illinois, Jan. 3, 2013
-- Enhanced Deliverability with New Drug Eluting Stent Delivery System
-- Leverages Proven Clinical Outcomes of XIENCE V® and XIENCE PRIME®
-- Offers the Largest Size Matrix in the U.S. Market
ABBOTT PARK, Illinois, 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
and for XIENCE PRIME at
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
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
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.
Contact: Media, Jonathon Hamilton, +1-408-845-3491; Financial, Tina Ventura,
Press spacebar to pause and continue. Press esc to stop.