The FDA issued healthcare providers updated guidance for certain warning language with paclitaxel-coated devices that treat peripheral arterial disease (PAD).
These 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.
Device manufacturers collaborated in an updated meta-analysis with patient follow-up ranging from 2-5 years. FDA clinicians and statisticians reviewed the study data. They concluded that the updated RCT meta-analysis does not indicate that the use of paclitaxel-coated devices is associated with a late mortality risk. The agency said longer-term follow-up in several of these studies continues as well.
FDA’s latest communication recommends that providers discuss risks and benefits of all PAD treatment options. That includes paclitaxel-coated devices. The agency also wants providers to routinely monitor patients treated with paclitaxel-coated balloons and stents. They should also ensure patients receive optimal medical therapy for PAD and other cardiovascular risk factors, the FDA said.
According to the FDA, it plans to work with device manufacturers to update product labeling based on current available data.
