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  • FDA Panel Says Lutonix 014 DCB Is Safe but Not Effective for BTK CLI

    • Posted: 02/17/2021
    • Author:

      Jason Wermers and Brian C. Case, CRTonline.org

    A U.S. Food and Drug Administration advisory panel recommended against premarket approval of the Lutonix 014 drug-coated balloon (DCB) to treat below-the-knee (BTK) critical limb ischemia (CLI) after a daylong virtual meeting Wednesday.

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