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The FDA's Circulatory System Devices Panel told the regulator that there is legitimate statistical evidence showing that treating blocked arteries in the legs with the drug paclitaxel is associated with higher rates of death years later in US patients, Star Tribune reported.
While Medtronic, Boston Scientific and other manufacturers of peripheral stents and drug-coated balloons had suggested that there is no elevated mortality signal in their own data, the FDA found an elevated risk when all the studies were pooled together.
Devices with paclitaxel have been studied extensively in clinical trials since the first one, Cook Medical's Zilver PTX peripheral stent, was approved by the FDA in 2012.
However, the panel said the studies collectively did such a poor job of tracking deaths over three to five years that the experts could not answer many of the FDA's other questions, such as whether the enhanced mortality rate applied to some or all of the devices.
Additionally, panel members said that the companies seemed to present different data than the FDA did, even though the regulator obtained its data from the companies themselves.
FDA panellist John Hirshfield said "we are being subjected to a forest of duelling numbers."
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