FDA Greenlights Clinical Studies of Paclitaxel Devices to Address Late Mortality Signal
The US Food and Drug Administration (FDA) gave manufacturers the go-ahead to continue enrollment in clinical studies of paclitaxel-coated devices to address a late mortality signal.FDA’s notice is part of a probe the agency launched in January after a 2018 meta-analysis concluded that there is an increased risk of late mortality among peripheral arterial disease (PAD) patients treated with a paclitaxel-coated balloon (DCB) or a paclitaxel-eluting stent (DES).
The update informs that FDA believes DCB and DES clinical studies “may continue,” citing the short-term benefits previous studies of both device types reportedly demonstrated, limitations in available data and the current uncertainty regarding long-term benefit-risk profiles. The verdict comes after an FDA advisory panel in June determined that a late mortality signal associated with the use of paclitaxel-coated devices in PAD patients does exist.
Panel members faced a “conundrum” due to conflicting analyses and data limitations. But discussions made clear that the signal is not well understood. FDA agrees that “additional clinical study data are needed to fully evaluate the late mortality signal.” The studies “should collect long-term safety (including mortality) and effectiveness data” and “require appropriate informed consent and close safety monitoring to protect enrolled patients,” the agency notes.
FDA is addressing the signal via updates to labels and informed consent protocols after the panel advised against pulling the devices from the market and is working with manufacturers and investigators to reflect signal information in labels and informed consent documents.
The agency’s notice was well-received by Cook Medical, Medtronic and Boston Scientific, which say that the move helps ensure access to their respective paclitaxel-coated devices. Medtronic notes that the guidance allows “FDA and industry to analyze additional randomized controlled trials and registry datasets to help provide more insights into the mortality signal in question.”
FDA