October 01, 2020 – Medtronic plc (Dublin, Ireland) received U.S. Food and Drug Administration (FDA) approval 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 DES.
According to the company, the Resolute Onyx DES is the first-and-only DES in the U.S. that has been proven safe and effective utilizing a one-month regimen of DAPT – the combination of aspirin and an anti-clotting medication – following a percutaneous coronary intervention (PCI) in patients at high bleeding risk.
In May, the Resolute Onyx was the first DES to receive CE Mark for a one-month DAPT indication for patients at high bleeding risk in Europe.