Private-Label Version of Abbott's XIENCE(TM)V Drug-Eluting Coronary Stent System Launches in Europe
11 Januar 2007 - 2:50PM
PR Newswire (US)
ABBOTT PARK, Ill., Jan. 11 /PRNewswire-FirstCall/ -- A
private-label version of Abbott's XIENCE(TM) V Everolimus Eluting
Coronary Stent System has launched in Europe, Boston Scientific
Corporation announced today. The PROMUS(TM) Everolimus-Eluting
Coronary Stent System is designed, studied and manufactured by
Abbott and supplied to Boston Scientific as part of a distribution
agreement between the two companies announced last year. Abbott
secured CE mark and launched the XIENCE V stent system in Europe in
October 2006, and it is currently available in most major European
and Asia-Pacific markets. The company expects to launch XIENCE V in
the U.S. in the first half of 2008. "We are pleased with today's
announcement, as it allows more patients to have access to the
advanced next-generation drug eluting stent technology that
underlies the XIENCE V system," said John M. Capek, Ph.D.,
president, Abbott Vascular. Additional Clinical Trial Results in
2007 Abbott will present results from the randomized portion of the
SPIRIT III pivotal trial in the first half of 2007. SPIRIT III is a
large-scale pivotal clinical trial comparing the XIENCE V
Everolimus Eluting Coronary Stent System to Boston Scientific's
TAXUS(R) Paclitaxel-Eluting Coronary Stent System. The XIENCE V
system is currently an investigational device in the United States
and Japan. Earlier this fall, Abbott presented 6-month results from
its SPIRIT II clinical trial at the World Congress of Cardiology
conference in Barcelona, Spain, that demonstrated superiority of
the XIENCE V Everolimus Eluting Coronary Stent System compared to
the TAXUS Paclitaxel-Eluting Coronary Stent System with respect to
the study's primary endpoint, which was angiographic in-stent late
loss at six months. About the XIENCE V Everolimus Eluting Coronary
Stent System The XIENCE V Everolimus Eluting Coronary Stent System
is based upon the highly deliverable and proven MULTI-LINK
VISION(R) coronary stent platform. The system utilizes everolimus,
which has been shown to reduce tissue proliferation in the coronary
vessels following stent implantation. SPIRIT Family of Trials The
SPIRIT Clinical Trial Program is designed to study the safety and
efficacy of the XIENCE V Stent System across five clinical trials.
The SPIRIT FIRST study of the XIENCE V Stent System showed positive
results through two years with no major adverse cardiac events
(MACE) between one and two years in patients with de novo native
coronary artery lesions. In addition to SPIRIT II, which was
conducted in Europe and Asia-Pacific, and SPIRIT III in the United
States and Japan, SPIRIT IV will evaluate the safety and efficacy
of the XIENCE V Stent System for the treatment of coronary artery
disease in a more complex patient population in the United States.
SPIRIT V is an international study that will provide additional
clinical experience with the XIENCE V Everolimus Eluting Coronary
Stent System at approximately 100 sites throughout Europe, Asia,
Canada and Africa. The trial consists of two concurrent studies, a
Diabetic Study and the Registry. The SPIRIT V Diabetic Study is a
prospective, randomized single-blind study comparing the XIENCE V
coronary stent system to the TAXUS(R) Liberte coronary stent system
in the treatment of diabetic patients with coronary artery disease.
The SPIRIT V Registry is a prospective, single-arm registry
evaluating performance of the XIENCE V Stent System in real-world
clinical settings. 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, effectiveness
and ease of use in treating patients with vascular disease. For
more information, visit http://www.abbott.com/. 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/. PROMUS(TM) and TAXUS(R) are
trademarks of Boston Scientific Corporation. DATASOURCE: Abbott
CONTACT: Media: Karin Bauer-Aranez, +1-408-845-3887, or Kelly
Morrison, +1-847-937-3802; or Financial: Tina Ventura,
+1-847-935-9390 Web site: http://www.abbott.com/ Company News
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