No Excess Mortality Risk for Paclitaxel-Coated Devices, FDA Says

After analyzing four additional years of data, the FDA has decided to reverse its 2019 judgment of the mortality risk of paclitaxel-coated devices, saying data do not support a finding of excess mortality risk.

In March 2019, the FDA had warned that use of the devices might be contributing to patient deaths. At the time, a provisional review of three clinical trials with at least five years of follow-up data found that peripheral arterial disease patients who received balloons or stents coated in paclitaxel were nearly 50 percent more likely to die than patients whose devices weren’t coated in paclitaxel (FDAnews, March 25, 2019).

On Wednesday, the agency updated its information on the devices, drawing on data from pivotal randomized controlled trials generated since 2019. Patient follow-up in the studies ranged from two to five years. — Karen Early

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