The Food and Drug Administration (FDA) announced that the Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet June 19-20, 2019, at the Gaithersburg Holiday Inn, Gaithersburg, Md., to “discuss and make recommendations on information related to recent observations of increased compared to patients treated with uncoated comparator devices.”
The FDA is requesting the panel’s input “regarding the presence and magnitude of the signal and potential causes.” In addition, the FDA will seek input “regarding appropriate regulatory actions associated with the findings.”
In a Letter to Healthcare Providers issued March 15, the FDA reported that their preliminary review of these data found “a potentially concerning signal of increased long-term mortality in study subjects treated with paclitaxel-coated products, compared to patients treated with uncoated devices.”
Their recommendation was: “Alternative treatment options should generally be used for most patients,” rather than paclitaxel-coated balloons and stents for peripheral arterial disease (PAD), pending the above announced ongoing safety review.
The FDA intends to make background material available to the public no later than 2 business days before the meeting on its website at the appropriate advisory committee meeting link.