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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 FDA said last week that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices compared to those treated with bare devices.