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LVD Biotech

Medtech manufacturers must add warning label to drug-eluting PAD devices

June 16, 2020 By Nancy Crotti

UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks. A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for […]

Filed Under: Business/Financial News, Drug-Device Combinations, Drug-Eluting Stents, Featured, Regulatory/Compliance, Stents, Vascular Tagged With: B. Braun, Biosensors International Group Ltd., Biotronik, Boston Scientific, Cook Medical, FDA, Lutonix Inc., LVD Biotech, Medtronic, Spectranetics Corp., U.K.medicinesandhealthcareproductsregulatoryagency

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