U.K. medtech regulators have recommended a ban on routine use of paclitaxel drug-coated balloons (DCBs) and drug-eluting stents in patients with intermittent leg cramps, but held back on recommending the same for patients with critical limb ischemia.
U.S., U.K. and French regulators began raising concerns about the risk of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices compared to those treated with bare devices following the December publication of a meta-analysis of patient outcomes.
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