New Data Raises Safety Concerns for Medtronic’s Endeavor Drug-Coated Stent

Article in the Wall Street Journal — New Data Raise Questions About Medtronic’s Stent, by Jon Kamp and Jennifer Corbett Dooren.  Here’s an excerpt:

The Food and Drug Administration released new data for Medtronic Inc.’s Endeavor drug-coated stent that raise new questions about the heart device’s performance and prospects, ahead of a regulatory review Wednesday.

Stents are small devices used to prop open heart arteries, and drug-coated stents use medication to slow renarrowing.

Avoiding stent-related clots has been Endeavor’s calling card in a market that has been rattled by concerns about late-developing clots. While there are no new signs that Endeavor doesn’t perform well over the long term, new data from the much-anticipated “Endeavor IV” study did show some earlier clots for Medtronic’s stent.

BGS