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Guidant receives CE Mark for drug eluting coronary stent
By Lisa Kerner
Erie, Pa., Jan. 30 - Guidant Corp. said it received CE Mark approval for its Xience V Everolimus Eluting Coronary Stent System. This regulatory certification allows Guidant to begin marketing the drug eluting stent in the European Union.
The Xience V Everolimus Eluting Coronary Stent System uses Guidant's most advanced coronary stent system, the cobalt chromium Multi-Link Vision, according to a company news release. Everolimus has been shown to reduce tissue proliferation in the coronary vessels following stent implantation.
Guidant is preparing its manufacturing and building inventory to supply ongoing clinical trials and to support the European launch of Xience V, expected to begin in the second quarter of 2006.
In November, Guidant completed enrollment of a 300-patient, randomized clinical trial evaluating Xience V, known as Spirit II. The single-blind, prospective, randomized, non-inferiority study further evaluates the Xience V compared to the Taxus Express 2 Paclitaxel-eluting coronary stent system for the treatment of coronary artery disease.
Guidant's 1,380-patient global clinical trial (Spirit III) is evaluating the Xience V Stent System in the United States and Japan, the company said. The randomized U.S. cohort has enrolled more than 70% of the required patients. Complete enrollment is expected later this quarter.
The CE Mark approval is used to support market registrations in other regulated countries including those within Asia, Latin America and Eastern Europe, according to a company news release.
Guidant designs and develops cardiovascular medical products. The company is based in Indianapolis.
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