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Safety Alerts and Recalls

‘Potentially Concerning’ Signal Identified in Long-Term Follow-up Data Involving Paclitaxel-Coated Products

A preliminary analysis of long-term follow-up data (up to 5 years) involving patients with peripheral arterial disease (PAD) treated with paclitaxel-coated products revealed a ‘potentially concerning’ signal of increased long-term mortality when compared with those treated with uncoated devices, according to the Food and Drug Administration (FDA). Among the 3 trials that included 5-year follow-up…