Guidant (NYSE:GDT)
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Guidant Corporation (NYSE:GDT) today announced that the
company has received Conformite Europeene (CE) Mark approval for the
XIENCE(TM) V Everolimus Eluting Coronary Stent System. This regulatory
certification allows Guidant to begin marketing the drug eluting stent
in the 25 countries of the European Union. In addition, the CE Mark
Approval is used to support market registrations in other regulated
countries including those within Asia, Latin America and Eastern
Europe.
"This early approval represents a significant milestone in
Guidant's drug eluting stent program and demonstrates our ongoing
commitment to advancing the field of cardiovascular therapy through
innovative solutions," said John M. Capek, Ph.D., president, Vascular
Intervention, Guidant. "The development of XIENCE V represents years
of hard work and dedication by our employees and by trial
investigators. We look forward to bringing this next-generation
therapy to physicians and patients."
The XIENCE V Everolimus Eluting Coronary Stent System utilizes
Guidant's most advanced coronary stent system, the highly deliverable
cobalt chromium MULTI-LINK VISION(R), which is available on the
preferred rapid-exchange platform. Everolimus has been shown to reduce
tissue proliferation in the coronary vessels following stent
implantation.
"Completion of the CE Mark approval process for XIENCE V follows
on the heels of impressive clinical results from the SPIRIT FIRST
trial, which demonstrated the benefits of an everolimus drug eluting
stent," said Prof. Patrick W. Serruys, M.D., of the Thoraxcenter,
Erasmus University Hospital, Rotterdam, who served as the study's
principal investigator. "With this approval, physicians in Europe will
have an excellent treatment option for patients requiring a drug
eluting stent."
Guidant is ramping up manufacturing and building inventory to
supply ongoing clinical trials and to support the European launch of
XIENCE V beginning in the second quarter of 2006.
In November, Guidant announced completion of enrollment in only
four months of SPIRIT II, a 300-patient, randomized clinical trial
evaluating XIENCE V. The single-blind, prospective, randomized,
non-inferiority study further evaluates the XIENCE V compared to the
TAXUS(R) Express 2(TM) Paclitaxel-eluting coronary stent system for
the treatment of coronary artery disease.
Guidant's 1,380-patient SPIRIT III global clinical trial is
evaluating the XIENCE V Stent System in the United States and Japan.
The randomized U.S. cohort, which will support U.S. Premarket Approval
submission, has enrolled more than 70 percent of the required patients
and is expected to complete enrollment later this quarter.
Guidant Corporation pioneers lifesaving technology, giving an
opportunity for better life today to millions of cardiac and vascular
patients worldwide. The company develops, manufactures and markets a
broad array of products and services that enable less invasive care
for some of life's most threatening medical conditions. For more
information visit www.guidant.com.
This release includes forward-looking statements concerning XIENCE
V. The statements are based on assumptions about many important
factors, including satisfactory enrollment and completion of the
clinical trial, associated regulatory processes and timelines, and
other factors identified on Exhibit 99 to the company's most recent
filing on Form 10-Q. Actual results may differ materially. The company
does not undertake to update its forward-looking statements.
NOTE TO MEDIA: For more information about Guidant, including its
products and services, please visit the company's newsroom at
www.guidant.com/newsroom.
Note to Editors: In the first graph, there should be an accent
mark over the "e" in "Conformite" and over the second "e" in
"Europeene."