HomeMEDTRONIC plcMedtronic Onyx ONE Clear Study of One-Month Dual-Antiplatelet Therapy in High Bleeding Risk Stent Patients Beats Performance Goal

Medtronic Onyx ONE Clear Study of One-Month Dual-Antiplatelet Therapy in High Bleeding Risk Stent Patients Beats Performance Goal

Medtronic plc today announced positive results of the Onyx ONE Clear Study that evaluated Resolute Onyx DES in high bleeding risk (HBR) patients with one-month dual antiplatelet therapy (DAPT) in the United States and Japan. The study met its primary endpoint of cardiac death or myocardial infarction by beating a performance goal derived from contemporary one-month DAPT trials at one-year post-procedure. Results from the study were shared virtually at the American College of Cardiology together with the World Congress of Cardiology Scientific Sessions (ACC.20/WCC) on March 28, 2020.

“Despite the high-risk population, we observed a low rate of ischemic outcomes after DAPT discontinuation at one month,” said Ajay Kirtane, M.D., professor of medicine at Columbia University Irving Medical Center, lead investigator and presenter of the data at ACC.20. “These data, in conjunction with the randomized data from the Onyx ONE Global randomized controlled trial, offer additional clinical evidence of one-month of DAPT for appropriately selected patients treated with the Resolute Onyx DES.”

The prospective, multicenter, single-arm study included highly complex HBR patients in the U.S. and Japan who were treated with one-month DAPT (the combination of aspirin and an anti-clotting medication) following PCI with Resolute Onyx and were clear of any adverse events and were DAPT compliant at one month. Patients in the Onyx ONE Clear Study were pooled with similar patients treated with Resolute Onyx from the Onyx ONE Global Study, totaling approximately 1500 patients that were included in the primary endpoint analysis. The Onyx ONE Clear study’s primary composite endpoint of cardiac death or myocardial infarction was 7.0%, beating the pre-specified performance goal of 9.7% at one-year post-procedure. The rate of stent thrombosis was low at 0.7% at one year1. The performance goal was based on short-DAPT studies.

The Onyx ONE Clear Study was designed to complement the Onyx ONE Global Study, results of which wererecently published in the New England Journal of Medicine2. Together, the Onyx ONE Clear Study and the Onyx ONE Global Study make up the robust Medtronic Onyx ONE Month DAPT Program that has enrolled approximately 2,700 patients at up to 130 sites worldwide.

“Onyx ONE Clear demonstrates our commitment to providing the clinical evidence of greatest interest and benefit to the interventional cardiology community,” 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. “We hope these data will support our submission to the FDA for a one-month DAPT indication for high-bleeding risk patients treated with Resolute Onyx.”

To date, more than 22,000 patients have been studied in Medtronic sponsored and funded clinical trials that have addressed DAPT duration. Resolute Onyx DES was approved in the U.S. in 2017 and is not currently indicated for high bleeding risk patients on one-month DAPT.

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.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Hinge Health Acquires the Most Advanced Computer Vision Technology for Tracking Human Motion

CEO Daniel Perez explained, “We won’t stop investing in technology to deliver the most patient-centered digital clinic that improves member experience and outcomes while reducing costs. wrnch allows us to take a giant leap forward in all respects.”

Dale W Wood Congratulates the Huma Team on Raising $130 Million

Major health and technology companies across the world have committed upwards of $130 million to Huma Therapeutics, the health-tech company backed by Dale Ventures.

Rhaeos Awarded $4 Million NIH SBIR Grant

Under the NIH SBIR grant, Rhaeos will leverage their existing wireless sensor hardware to provide additional quantitative flow data to the clinician, giving insight into this currently inaccessible and highly relevant shunt performance metric.

Gynesonics Announces FDA Clearance of Next Generation Sonata System

“This clearance brings significant system improvements that expand the location of fibroids that can be treated while allowing the physician to control all aspects of the treatment from within the sterile field,” said Jiayu Chen, Ph.D. Vice President, Engineering and Advanced Technologies at Gynesonics.

Blackrock Neurotech Invests In Groundbreaking Auditory Nerve Implant With University Of Minnesota And MED-EL

The new investment will enable the development and translation of a new ANI through preclinical studies and later, a pilot clinical trial, where the ANI is then implanted in up to three deaf patients.

Jonathan Chapman: New President/CEO of Trividia Health

Chapman said, “I’m honored to join the Trividia team as President and CEO. This organization has a long history of leadership within the healthcare industry as a provider of accurate, accessible, and affordable point-of-care solutions for the management of diabetes.”

SOLOPASS® System (Bedside Neuro-Navigation Device) Receives FDA 510(k) Clearance

inTRAvent’s SOLOPASS® system brings simple, portable, bedside neuro-navigation into the intensive care unit.

Skyhawk Therapeutics Completes New Investment Round

A $133 million round of investment will allow Skyhawk to accelerate development of its novel small molecule RNA-modifying drug candidates into the clinic.

By using this website you agree to accept Medical Device News Magazine Privacy Policy