Stent :: More caution concerning coated stents – FDA warnings

A panel of experts recommended that doctors and patients be given stronger warnings about the dangers associated with the use of drug-coated stents in high-risk patients.

Based on the finding, the special 21-member Food and Drug Administration panel recommended that the agency issue new warnings to doctors and patients that the devices’ safety has not been established except for relatively low-risk patients, for whom the stents were originally tested and approved.

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