FDA Approves New Medtronic Stent in Spite of Report

Joe Saunders

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In spite of a recent scientific report citing certain health risks, the FDA voted to approve Medtronic's new cardiac stent, Endeavor. Data published a few days before the vote raised questions about the risk of blood clots linked to use of the drug coated stent. However, the FDA panel did suggest the FDA require that Medtronic conduct a 5 year post-approval study to assess the risks potentially associated with the new cardiac stent.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.