Medtronic stent clears FDA approval hurdle

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A federal advisory panel of outside experts unanimously recommended that the U.S. FDA regulators approve Medtronic’s Endeavor drug-eluting stent, along with a requirement for follow-up safety studies, according to Karen Riley, an FDA spokeswoman.

Medtronic of Minneapolis presented the results for its Endeavor stent clinical studies, which were observed by the advisory panel, to an FDA panel yesterday.

If the FDA accepts the advisory panel’s proposal, Medtronic will be the third drug-eluting stent to enter the U.S. market. The New York Times (NYT) reported that the FDA panel is expected to accept the recommendation, and if it does, Medtronic is expected to release Endeavor by year’s end.

Although the FDA is not required to follow the panel's advice, most analysts expect the agency to give Medtronic approval later this year.

Thrombosis, myocardial infarction and death were the three main concerns raised at an FDA advisory panel meeting held at the end of last year to discuss the safety of Boston Scientific’s Taxus paclitaxel-eluting stent and Johnson & Johnson's subsidiary Cordis’ Cypher sirolimus-eluting stent.

The panelists also suggested that Medtronic should be required to track the health of 5,000 patients with the device for at least five years.

The NYT reported that Endeavor could attain between 12 and 18 percent of the domestic drug-eluting stent market in the first year. The only aspect that could interfere with Medtronic’s projected sales is the introduction of a fourth drug-coated stent, Xience V from Abbott Laboratories, according to The NYT.