Healthcare Industry News: SPIRIT II
News Release - January 24, 2006
Guidant Receives Recommendation for Approval from European Competent Authority for Drug Eluting StentCompany Has Successfully Completed Conformity Assessment and Facility Audit by Notified Body
CE Mark Certificate Expected in 7-10 Days
INDIANAPOLIS & BRUSSELS, Belgium--(HSMN NewsFeed)--Jan. 24, 2006--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®, 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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