UPDATED INFORMATION – February 20, 2024 Health Canada worked with manufacturers, clinicians, and other international health regulatory agencies to further assess the risk of increased mortality associated with the use of paclitaxel-coated devices used to treat peripheral arterial disease (PAD). Based on all available clinical evidence, Health Canada did not identify an increased risk of mortality associated with the use of these devices when used in accordance with the licensed indications. This information aligns with the U.S. Food and Drug Administration (US FDA) recommendations of July 11, 2023 and recommendations made by Health Canada’s Scientific Advisory Committee on Medical Devices Used in the Cardiovascular System (SAC-MDUCS) in November 2023. This update applies to all paclitaxel-coated device models. Please note that the communication issued on May 6, 2019 (see below), is no longer reflective of the current Health Canada findings. Healthcare professionals are advised to use the paclitaxel-coated devices in accordance with the licensed indications outlined in the labeling material. May 6, 2019 A potential increased risk of long-term, all-cause mortality (at 2 years to 5 years) after the use of PCB and PES for the treatment of PAD was identified in a meta-analysis , which was published in the Journal of the American Heart Association (JAHA) in December 2018. 1 The reason for the potential increased risk of death is not yet known. Health Canada is currently evaluating this safety concern to determine if there is an increased long-term mortality risk associated with paclitaxel ‐ containing devices used for PAD treatment.
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