FDA, industry do not agree on late mortality signal for paclitaxel devices in PAD treatment
GAITHERSBURG, Md. – Food and Drug Administration (FDA) officials said the data they presented Wednesday during an advisory panel meeting appear to show a signal for an increased risk of mortality beyond 1 year for paclitaxel-coated devices used to treat peripheral arterial disease (PAD) compared with non-paclitaxel devices.