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Cordis
Resolves FDA CYPHER Stent Warning Letter Company May Now Seek Expanded Indications and Introduce Next-Generation CYPHER Drug-Eluting Stents |
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| The original complaint was issued one year after the FDA originally okayed the CYPHER stent, the first drug-eluting stent to gain US approval. The warning letter described problems found at CYPHER stent plants in the Netherlands, Belgium, Puerto Rico, as well as U.S. sites in New Jersey and Florida. They involved documentation, packing and storage, complaint processing, and manufacturing processes. At the time FDA spokesperson Sharon E. Snider stated, "Patients who have these stents should not be concerned." No stent was recalled and a Cordis spokesperson stated that the FDA observations came about as part of the standard post-approval inspections and that Cordis has been actively engaged with the FDA from the beginning to resolve the outstanding issues. The three year period that it took to resolve the warning letter was far longer than originally predicted. Currently Boston Scientific, Cordis' only drug-eluting stent competitor in the U.S. market, is operating under a similar warning letter, issued in January 2006. Boston Scientific initially had hoped for resolution within the year -- the company is now hoping for later this year. The lifting of the warning letter means that Cordis is now free to seek expanded indications for the CYPHER stent, and to submit next generation devices for approval. Currently, the company markets a "more deliverable" version of the CYPHER in Europe. |
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