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Abbott Receives CE Mark for Smaller-Size XIENCE™ V Drug Eluting Stent
New 2.25 mm Diameter Stent Now Available in Europe, Asia and Latin America
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March 11, 2008 -- Abbott Park, Illinois -- Abbott announced today that it has received CE Mark (Conformité Européene) approval for a 2.25 mm version of its XIENCE™ V Everolimus Eluting Coronary Stent System, offering physicians a smaller stent based upon the proven efficacy, positive safety results and excellent deliverability of XIENCE V. The addition of the 2.25 mm stent to the XIENCE V portfolio gives physicians access to a wider range of stent sizes for treating a variety of patient types.
"Lesions in small vessels tend to be more complex and challenging to treat, so it's important to have a drug eluting stent with proven clinical benefits that can be easily delivered to the diseased area of the vessel," said Charles Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs and chief medical officer, Abbott Vascular. "With XIENCE V 2.25 mm, physicians now have access to a smaller stent that combines these critical attributes with the positive safety outcomes we have seen with XIENCE V. These outcomes include low rates of reintervention in the diseased vessel, low rates of heart attack and death, and low rates of vessel renarrowing following treatment."
The 2.25 mm version of the XIENCE V stent will be launched immediately in the majority of European markets and select countries in Asia and Latin America. In addition to the 2.25 mm stent, XIENCE V is available in stent diameters of 2.5 mm, 2.75 mm, 3.0 mm, 3.5 mm and 4.0 mm for lesions 28 mm or shorter.
Coronary artery disease (CAD) occurs when arteries become narrow due to plaque buildup, restricting blood flow to the heart. Approximately 30 to 40 percent of CAD lesions occur in vessels equal to or less than 2.5 mm in diameter.
XIENCE V is the only drug eluting stent to demonstrate superiority over another drug eluting stent in a randomized clinical trial. In the SPIRIT family of trials, XIENCE V demonstrated:
- Superiority for XIENCE V compared to
TAXUS® paclitaxel eluting coronary stent system in the primary
endpoint of angiographic In-Stent Late Loss in the SPIRIT II
clinical trial at six months, with a statistically significant
69 percent reduction for XIENCE V. In-stent late loss is a measure
of vessel renarrowing within the margins of the stent.
- Superiority
for XIENCE V compared to the TAXUS in the primary endpoint
of angiographic In-Segment Late Loss at eight months in the SPIRIT
III clinical trial, with a statistically significant 50 percent
reduction for XIENCE V. In-segment late loss is a measure of
vessel renarrowing.
- An observed 43 percent reduction in major
adverse cardiac events (MACE)
compared to TAXUS at one year in SPIRIT III. MACE is an important
clinical measure of safety and efficacy outcomes for patients,
and is defined as cardiac death, heart attack (myocardial
infarction or MI), or ischemia-driven target lesion revascularization
(TLR associated with symptoms or documented lack of blood supply).
- Non-inferiority
to TAXUS with an observed 23 percent reduction in
Target
Vessel Failure (TVF) for XIENCE V compared to TAXUS in
the SPIRIT III clinical trial at one year. Target Vessel Failure
is a measure
of re-treatment anywhere within the target vessel and includes
cardiac death or heart attack.
Additionally, data from an independent pooled subset analysis of SPIRIT
II and SPIRIT III at one year showed:
- A statistically significant
59 percent reduction in angiographic In-Stent Late Loss for XIENCE
V compared to TAXUS for lesions in a
reference vessel diameter less than 2.5 mm.
- An observed 61 percent
reduction in angiographic In-Segment Late Loss for XIENCE V compared
to TAXUS for lesions in a reference vessel diameter less than
2.5 mm.
XIENCE V was launched in Europe and other international markets in
late 2006. XIENCE V is an investigational device in the United States
and Japan, and is currently under review for approval by the U.S. Food
and Drug Administration.
Abbott also supplies a private-label version of XIENCE V to Boston
Scientific called the PROMUS™ Everolimus-Eluting Coronary Stent System.
PROMUS is designed, studied and manufactured by Abbott and supplied
as part of a distribution agreement between the two companies.
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 that are recognized internationally for their
safety and effectiveness in treating patients with vascular disease.
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 65,000 people and markets its products in more
than 130 countries.
Source: Abbott
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