Guidant Receives Recommendation for Approval from European Competent Authority for Drug Eluting Stent; Company Has Successfully
24 Janvier 2006 - 9:41PM
Business Wire
Guidant Corporation (NYSE:GDT) today announced that the company's
XIENCE(TM) V Everolimus Eluting Coronary Stent System has been
recommended for approval by its European Competent Authority. In
addition, the company has successfully completed the Conformity
Assessment process and facility audit by its European Notified
Body. Guidant expects to receive the CE Mark certificate within the
next 7 to 10 days. "This positive news is a significant step
forward in bringing this next-generation therapy to physicians in
Europe," said John M. Capek, Ph.D., president, Vascular
Intervention, Guidant. "We are pleased that we have arrived at this
point in the European approval process much sooner than we had
anticipated. We are ramping up manufacturing and building inventory
to supply our ongoing clinical trials and to support the European
launch of XIENCE V in the second quarter." 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 rapid-exchange
platform physicians prefer. Everolimus has been shown to reduce
tissue proliferation in the coronary vessels following stent
implantation. 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(TM)
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.
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