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Three Boston Scientific Products on Hold Until FDA Warning Is Lifted

Posted on March 26, 2008 @ 08:35 am



Three Boston Scientific cardiovascular products are ready to be launched this year if a 2006 corporate warning letter is lifted. FDA inspections required to lift the warning letter began Feb. 1, Paul LaViolette, Boston Scientific’s chief operation officer, said. In deference to the agency, he would not comment further on the progress of the inspections. The January 2006 letter cited Boston Scientific for “inadequate corporatewide corrective action plans.” One product with an approvable letter is the Taxus Liberte drug-eluting stent. Boston Scientific will be “on the offensive” in the drug-eluting stent market this year, LaViolette said. The company also expects its Promus stent will be approved in the middle of this year. The Carotid Wallstent — the No. 1 stent outside the U.S. — also has an approvable letter contingent on the warning letter resolution, as does the Express SD renal stent, he said.