Medtronic has received Conformité Européenne (CE) 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).
The indication enables physicians to recommend a shorter, one-month regimen of DAPT, following a percutaneous coronary intervention (PCI) with Resolute Onyx for HBR patients.
The company noted that the approval is the first of its kind globally. It is based on results from the Onyx ONE Global Study, the first prospective, randomised, one-month DAPT trial comparing Resolute Onyx to a competitive DES in nearly 2,000 HBR patients.
In the study, Resolute Onyx met its primary composite endpoint of cardiac death, myocardial infarction (MI) or stent thrombosis (ST) at one-year showing non-inferiority versus its competitive DCS.
Medtronic Cardiac and Vascular Group, Coronary and Renal Denervation business vice-president and general manager Dave Moeller said: “The growing body of clinical evidence supports the use of Resolute Onyx to meet the needs of complex patient populations.
“Resolute Onyx has shown exceptional outcomes in complex patient populations and anatomies, including those at a high risk of bleeding, which has helped pave the way for this first-of-its-kind approval.”
Resolute Onyx DES is now available for use in the US and Europe and other countries that recognise the CE Mark. It is not currently indicated for HBR patients with one-month DAPT in the US.
Medtronic has submitted data to the Food and Drug Administration (FDA) for obtaining a one-month DAPT US Indication for Resolute Onyx DES.
More than 22,000 patients have been studied in Medtronic sponsored and funded clinical trials that have addressed DAPT duration, the company noted.