Medtronic Expands Indications for the Resolute Onyx DES in Europe

Medtronic has scored CE mark for a unique indication for the Resolute Onyx drug-eluting stent. The Dublin-based company said the approval was for a DAPT indication for high bleeding risk (HBR) patients. The firm said for HBR patients whose bleeding risk may be increased by taking longer DAPT regimens (a combination of aspirin and anti-clotting medication), this new, indication allows physicians to recommend a shorter, one-month regimen of DAPT, following a percutaneous coronary intervention (PCI) with Resolute Onyx. The indication is based on results from the Onyx ONE Global Study, a prospective, randomized, one-month DAPT trial comparing Resolute Onyx to the BioFreedom DCS 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 vs. BioFreedom DCS. Results from the global study were shared during a Late-Breaking Clinical Trial session at the 31st Transcatheter Cardiovascular Therapeutics Conference in September 2019 and were also published in the New England Journal of Medicine. "The growing body of clinical evidence supports the use of Resolute Onyx to meet the needs of complex patient populations,” Dave Moeller, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic, said in a release. “Resolute Onyx has shown ...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Cardiovascular Source Type: news