In a new field safety notice, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) states that a warning and clinical summary section will be added to the instructions for use (IFU) of 12 paclitaxel-coated balloons and paclitaxel-eluting stents used in the treatment of peripheral arterial disease (PAD) of the lower limbs.
The medical devices that will be affected by the changes are BioPath (Biosensors International), ELUVIA (Boston Scientific), IN.PACT Admiral (Medtronic), IN.PACT Pacific (Medtronic), Luminor (iVascular), Lutonix (BD), Passeo-18 Lux (Biotronik), Ranger (Boston Scientific), Ranger SL (Boston Scientific), SeQuent Please OTW (B Braun), Stellarex (Philips), and Zilver PTX (Cook Medical).
The notice states that updates will be made to the IFUs for these devices throughout Europe, including a warning and a summary of the December 2018 meta-analysis by Konstantinos Katsanos, MD, of the University of Patras, Patras, Greece, et al, which found an increased risk of death at two and five years following the application of paclitaxel-coated balloons and stents in the femoropopliteal artery in the studies analyzed.
The notice clarifies that no product batch/lot is being recalled in relation to this field safety notice, noting in its first appendix that “the benefits of paclitaxel-coated devices (e.g. reduced reinterventions) should be considered in individual patients along with potential risks (e.g. late mortality,” and urges physicians to discuss this late mortality signal and the benefits and risks of available treatment options with patients.
Click here to read the full field safety notice.