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FDA warning re paclitaxel coated stents and balloons

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Whalatane   Saturday, 05/18/19 03:02:01 PM
Re: None
Post # of 44 
FDA warning re paclitaxel coated stents and balloons in PAD

"There is strong evidence from statistical inference that the risk of death is significantly increased beyond the first year following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg in patients with intermittent claudication."

FDA wants interventionists to use alternative options ....SWAV's S4 will be an option especially the smaller sized 2.5m and 3 m versions that will be available Q4 2019

Kiwi


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