30.01.2006 19:02:00
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Guidant Receives European Approval for Drug Eluting Coronary Stent; Company Achieves CE Mark Approval Ahead of Schedule; XIENCE V Launch Slated for Second Quarter
"This early approval represents a significant milestone inGuidant's drug eluting stent program and demonstrates our ongoingcommitment to advancing the field of cardiovascular therapy throughinnovative solutions," said John M. Capek, Ph.D., president, VascularIntervention, Guidant. "The development of XIENCE V represents yearsof hard work and dedication by our employees and by trialinvestigators. We look forward to bringing this next-generationtherapy to physicians and patients."
The XIENCE V Everolimus Eluting Coronary Stent System utilizesGuidant's most advanced coronary stent system, the highly deliverablecobalt chromium MULTI-LINK VISION(R), which is available on thepreferred rapid-exchange platform. Everolimus has been shown to reducetissue proliferation in the coronary vessels following stentimplantation.
"Completion of the CE Mark approval process for XIENCE V followson the heels of impressive clinical results from the SPIRIT FIRSTtrial, which demonstrated the benefits of an everolimus drug elutingstent," said Prof. Patrick W. Serruys, M.D., of the Thoraxcenter,Erasmus University Hospital, Rotterdam, who served as the study'sprincipal investigator. "With this approval, physicians in Europe willhave an excellent treatment option for patients requiring a drugeluting stent."
Guidant is ramping up manufacturing and building inventory tosupply ongoing clinical trials and to support the European launch ofXIENCE V beginning in the second quarter of 2006.
In November, Guidant announced completion of enrollment in onlyfour months of SPIRIT II, a 300-patient, randomized clinical trialevaluating XIENCE V. The single-blind, prospective, randomized,non-inferiority study further evaluates the XIENCE V compared to theTAXUS(R) Express 2(TM) Paclitaxel-eluting coronary stent system forthe treatment of coronary artery disease.
Guidant's 1,380-patient SPIRIT III global clinical trial isevaluating the XIENCE V Stent System in the United States and Japan.The randomized U.S. cohort, which will support U.S. Premarket Approvalsubmission, has enrolled more than 70 percent of the required patientsand is expected to complete enrollment later this quarter.
Guidant Corporation pioneers lifesaving technology, giving anopportunity for better life today to millions of cardiac and vascularpatients worldwide. The company develops, manufactures and markets abroad array of products and services that enable less invasive carefor some of life's most threatening medical conditions. For moreinformation visit www.guidant.com.
This release includes forward-looking statements concerning XIENCEV. The statements are based on assumptions about many importantfactors, including satisfactory enrollment and completion of theclinical trial, associated regulatory processes and timelines, andother factors identified on Exhibit 99 to the company's most recentfiling on Form 10-Q. Actual results may differ materially. The companydoes not undertake to update its forward-looking statements.
NOTE TO MEDIA: For more information about Guidant, including itsproducts and services, please visit the company's newsroom atwww.guidant.com/newsroom.
Note to Editors: In the first graph, there should be an accentmark over the "e" in "Conformite" and over the second "e" in"Europeene."
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