Panel to Review Abbott Labs' Stent Data

NEW YORK (Associated Press) - The Food and Drug Administration said Tuesday it will ask an outside panel of medical experts whether clinical trial data submitted by Abbott Laboratories in support of its proposed cardiac stent Xience is enough to show it's safe and effective.
The panel also will be asked if patients in ongoing clinical studies of the drug-coated stent should be followed for a longer period of time before the agency considers approving the device.
The stent faces a review Thursday by the panel, which will make recommendations on whether the FDA should approve the device. The FDA usually follows its panel's advice but is not required to do so.
Most of the clinical studies compared Xience to Boston Scientific Corp.'s Taxus drug-coated stent, and involved about 1,000 patients. The bulk of the data pertains to patient outcomes after one year, although Abbott recently submitted additional data on 422 patients who have had the Xience stent for two years, compared with 181 patients with the Taxus stent.

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