Based on a meta-analysis of randomized trials for paclitaxel-coated devices, the FDA is concerned that they may not be safe to use, as they may be linked to mortality. Until further information is available, the FDA is recommending doctors prescribe these devices on a case-by-case basis only.
Author: Informa Pharma Intelligence
Published: 08 August 2019
Number of pages:3
The FDA is questioning the safety of paclitaxel-coated devices after a meta-analysis of randomized trials found such devices might pose mortality risk. The FDA will begin to update the device labels and provide informed consent documents to those involved in its clinical trials to reflect these concerns. Until more clinical trials are available, the FDA recommends doctors prescribe paclitaxel-coated devices with caution and closely monitor patients using them. For patients with high risk for restenosis and repeat femoropopliteal interventions, the devices still may be the best option. Current available data have clear limitations, so more clinical research is needed to understand the devices and their risks fully.
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