Medtronic Resolute Onyx DES Receives First and Only One-Month DAPT Indication for High Bleeding Risk Patients in Europe - Seite 2

The indication is based on results from the Onyx ONE Global Study, the first prospective, randomized, one-month DAPT trial comparing Resolute Onyx to a competitive DES (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 versus BioFreedom DCS. Results from the global study were shared during a Late-Breaking Clinical Trial session at the 31^st Transcatheter Cardiovascular Therapeutics (TCT) Conference in September 2019 and were also published in the New England Journal of Medicine³.

"The growing body of clinical evidence supports the use of Resolute Onyx to meet the needs of complex patient populations,” said 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. “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.”

The Onyx ONE Global Study, together with the Onyx ONE Clear Study, a study that evaluated Resolute Onyx DES in HBR patients with one-month DAPT in the United States and Japan, make up the robust Medtronic Onyx ONE Month DAPT Program that has enrolled approximately 2,700 patients at up to 130 sites worldwide. To date, more than 22,000 patients have been studied in Medtronic sponsored and funded clinical trials that have addressed DAPT duration.

In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.