Medtronic Resolute Onyx DES Receives First and Only One-Month DAPT Indication for High Bleeding Risk Patients in Europe

DUBLIN, June 05, 2020 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received CE (Conformité Européenne) Mark for a one-month dual antiplatelet therapy (DAPT) indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx Drug-Eluting Stent (DES). For HBR patients, whose bleeding risk may be increased by taking longer DAPT regimens (a combination of aspirin and anti-clotting medication), this new, first-of-its-kind indication allows physicians to recommend a shorter, one-month regimen of DAPT, following a percutaneous coronary intervention (PCI) with Resolute Onyx. The approval is the first of its kind globally. Resolute Onyx DES is available for use in the United States, as well as in Europe and other countries that recognize the CE Mark. Resolute Onyx DES is not currently indicated for HBR patients with one-month DAPT in the United States. Data have been submitted to the FDA with the intent of obtaining a one-month DAPT US Indication for Resolute Onyx DES.

HBR patients – including older patients, those with history of bleeding, or those on oral blood-thinning drugs – are a complex patient population that makes up nearly 40 percent of all PCI patients¹. HBR patients on longer DAPT regimens are three times more likely to have bleeding events than the general population undergoing PCI². Due to its biocompatible polymer and the ability to promote fast vessel healing, the Resolute Onyx DES has demonstrated through pre-clinical and clinical studies that it is well-suited for patients who may benefit from a shorter DAPT duration.^3,4

“The use of DAPT for DES is a challenge for HBR patients who may not be able to safely tolerate the same therapy duration as recommended for the broader patient population,” said Azeem Latib, M.D., section head of interventional cardiology & medical director of structural heart interventions at Montefiore Medical Center in New York City. “Through the Onyx ONE Global Clinical Program, we have observed that Resolute Onyx DES with one-month of DAPT in these complex patients is safe and effective. This indication will further substantiate the option for shorter DAPT regimens, if individual patient needs demand it.”