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BioWorld - Wednesday, April 15, 2026
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Home » Medtronic gets FDA nod for expanded labeling with Resolute Onyx DES
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Medtronic gets FDA nod for expanded labeling with Resolute Onyx DES

Oct. 2, 2020
By Liz Hollis
Medtronic plc’s winning streak continued this week with the announcement that the U.S. FDA had given its nod for new one-month of dual-antiplatelet therapy (DAPT) labeling with an expanded indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx drug-eluting stent (DES). The approval is based on results from the Onyx ONE Clear Study that evaluated about 1,500 complex HBR patients on one-month DAPT treated with Resolute Onyx.
Medical technology Regulatory Drug eluting stent Cardiovascular FDA PMA

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