Press Release
Abbott Receives CE Mark for Company's Next-Generation XIENCE PRIME™ Drug Eluting Stent, Advancing Leadership Position
Broad Size Matrix of XIENCE PRIME to be Launched in Europe in the Third
Quarter
June 23, 2009
Abbott Park, Illinois (NYSE: ABT)
— Abbott announced today that it has received CE
Mark (Conformité Européenne) for its next-generation XIENCE PRIME™ Everolimus Eluting Coronary Stent System
for the treatment of coronary artery disease. The company plans to launch XIENCE PRIME in a broad size matrix with lengths up to
38 mm in Europe in the third quarter.
"XIENCE PRIME leverages and will build upon the outstanding body of
clinical evidence from the SPIRIT family of clinical trials. The modified
design features of the stent and delivery system are intended to make it easier
for physicians to deliver the stent to the treatment area," said Robert
Hance, senior vice president, vascular, Abbott. "As part of Abbott's
leadership in drug eluting stents, we are committed to advancing treatment
options and look forward to making the innovative XIENCE
PRIME stent available to physicians and patients in Europe in the
upcoming months."
XIENCE PRIME utilizes the same well-studied drug and proven biocompatible
polymer as Abbott's market-leading XIENCE V®
Everolimus Eluting Coronary Stent System. In addition, it offers a novel stent
design and a modified delivery system designed for greater flexibility and
improved deliverability. XIENCE PRIME uses cobalt
chromium technology, which allows for very thin struts while maintaining
strength to support the vessel as well as excellent visibility under X-ray
during the stent implantation procedure. XIENCE
PRIME is based upon the proven design of the MULTI-LINK® family of
stents, which is the most widely used stent platform in the world – more than 2
million of Abbott's cobalt chromium stents have been implanted worldwide. Upon
launch in Europe, XIENCE PRIME will be available in an expanded size matrix,
including XIENCE PRIME SV for small vessels and
XIENCE PRIME LL for long lesions.
Abbott's robust vascular research program includes clinical trials in
coronary artery disease and peripheral artery disease. Key products in the
vascular pipeline include: the MULTI-LINK 8™
Coronary Stent System, a next-generation frontline balloon dilatation catheter,
a fully bioabsorbable drug eluting coronary device, and the Omnilink Elite™
Peripheral Stent System.
The MULTI-LINK 8 Coronary Stent System, the next-generation frontline
balloon dilatation catheter, the fully bioabsorbable drug eluting device and
the Omnilink Elite Peripheral Stent System are in development and are not
available for sale.
XIENCE PRIME currently is an investigational device in the United States and
not available for sale.
About XIENCE V
Abbott's market-leading XIENCE V drug eluting stent is marketed in the
United States, Europe and other international markets. 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.
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 (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 more than
72,000 people and markets its products in more than 130 countries.
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