More data is needed on devices that elute the drug paclitaxel to determine if they pose a higher mortality risk than non-eluting devices in treating peripheral artery disease, the FDA said ahead of an advisory panel meeting today.
A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated balloons and stents could be at a higher risk for late death. Led by Dr. Konstantinos Katsanos, researchers looked at data from 28 trials to find a 68% relative risk increase in all-cause death with paclitaxel-coated devices after two years and a 93% relative risk increase after five years, compared to therapy with an uncoated device.
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