The Wall Street Journal-20080204-Medtronic Is Cleared To Sell Stent

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Medtronic Is Cleared To Sell Stent

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The Food and Drug Administration Friday cleared Medtronic Inc. to sell its Endeavor drug-coated stent in the U.S., marking the first approval for this type of heart device in nearly four years and Medtronic's entry into a battered but still significant market.

As a condition of approval, the FDA required an extensive effort to continue tracking and reporting on outcomes with Endeavor for five years. The agency also required for the first time that all makers of coated stents, including Medtronic, study how long patients should take anticlotting drugs after getting a stent.

Coronary stents are tiny metal devices used to prop open heart arteries, and coated stents such as Endeavor use medication to combat renarrowing, which can be an issue with older bare-metal devices. The market for coated stents has been buffeted for more than a year by worries about safety with first-generation devices.

Endeavor will compete against stents made by Johnson & Johnson and Boston Scientific Corp. Meanwhile, an FDA panel of outside experts meeting in late November recommended U.S. approval for Abbott Laboratories' Xience stent. Abbott has said that approval could come in the second quarter this year.