The FDA issued healthcare providers updated guidance for certain warning language with paclitaxel-coated devices that treat PAD.
These peripheral arterial disease (PAD)-treating devices produced data that does not support an excess mortality risk. Specifically, the FDA’s guidance eliminates the need for certain warning language in the device labeling.
An FDA panel in 2019 determined that the agency needed more data on these devices to pin down the cause of death. The agency at the time acknowledged that a mortality signal indicated by a meta-analysis exists. The agency then issued a letter to healthcare providers declaring its need for more long-term safety and effectiveness data.
According to the FDA, it now has additional data relating to its previous communications asking for more. The agency said it worked with device manufacturers and external stakeholders to develop the protocol and analysis plan for this new data.
