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Abbott Gains Reimbursement for XIENCE(TM) V Drug Eluting Stent in France

Geschrieben am 01.02.2008 - [Nächster Artikel]

Abbott Park, Illinois (ots/PRNewswire) -

- Improved Medical Benefit Rating Granted for XIENCE V from French
Health Authority

Abbott (NYSE: ABT) today announced that it has received
reimbursement approval in France for its XIENCE(TM) V Everolimus
Eluting Coronary Stent System, the first drug eluting stent to
demonstrate clinical superiority over another drug eluting stent in a
randomized clinical trial.

Recognizing superior clinical results for XIENCE V compared to the
TAXUS(R) paclitaxel-eluting coronary stent system in the SPIRIT II
and III randomized clinical trials, the French Health Authority
(Haute Autorite de Sante) granted XIENCE V an ASA Level IV medical
benefit rating (Amelioration du Service Attendu). This distinction
recognizes an improved medical benefit for XIENCE V compared to
TAXUS. Abbott's XIENCE V drug eluting stent will become available to
all public and private hospitals throughout France in February.

"By awarding XIENCE V reimbursement and a higher medical benefit
rating than previous generation drug eluting stent technology, the
French Health Authority has recognized that XIENCE V represents an
important advancement in treatment," said John M. Capek, Ph.D.,
executive vice president, Medical Devices, Abbott. "Abbott looks
forward to introducing XIENCE V as a new standard of care in the
treatment of coronary artery disease to physicians and patients in
France."

The French Health Authority based its reimbursement evaluation for
Abbott's XIENCE V drug eluting stent on the results from three
randomized clinical trials: SPIRIT FIRST, SPIRIT II and SPIRIT III.
In this SPIRIT family of trials, XIENCE V demonstrated:


-- Superiority for XIENCE V compared to TAXUS in the primary endpoint of
in-segment late loss at eight months in the SPIRIT III clinical
trial, with a statistically significant 50 percent reduction in late
loss 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.
-- Superiority for XIENCE V compared to TAXUS in the primary endpoint of
angiographic in-stent late loss in the SPIRIT II clinical trial at
six months. In-stent late loss is a measure of vessel renarrowing
within the margins of the stent.


"The development and availability of new and improved therapies to
treat heart disease in France is critical to improving public
health," said Marie-Claude Morice, M.D., Institut Cardiologique Paris
Sud, Massy, France. "The availability of the XIENCE V drug eluting
stent in France is in the best interests of our physicians and
patients."

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(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.

About Abbott

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.

Web site: http://www.abbott.com

ots Originaltext: Abbott Laboratories
Im Internet recherchierbar: http://www.presseportal.de

$story.getcontactHeadline()
media in France, Francoise Poterre, +01-45-60-13-32,
francoise.poterre@abbott.com; or all other media, Kelly Morrison,
+1-847-937-3802; or Karin Bauer Aranaz, +1-408-845-3887; or
financial, Tina Ventura, +1-847-935-9390, all for Abbott
 
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