The FDA wrote a letter to healthcare providers yesterday on the heels of a meta-analysis that suggested an increased mortality rate after two years in people with peripheral artery disease who were treated with paclitaxel-coated and paclitaxel-eluting devices compared to bare devices.
The agency is “evaluating” the new information presented by the study and recommended that healthcare providers continue closely watching patients who have been treated with the drug-eluting devices.
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