Abbott (ticker: ABT, exchange: New York Stock Exchange (.N))
News Release -
Abbott Receives CE Mark for Smaller-Size XIENCE(TM) V Drug Eluting StentNew 2.25 mm Diameter Stent Now Available in Europe, Asia and Latin America
ABBOTT PARK, Ill., March 11, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Abbott
(NYSE: ABT) announced today that it has received CE Mark (Conformite
Europeene) approval for a 2.25 mm version of its XIENCE(TM) 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
"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
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
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
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(R) 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
- 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
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
Abbott also supplies a private-label version of XIENCE V to Boston
Scientific called the PROMUS(TM) 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.
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 65,000 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 http://www.abbott.com.