Medtronic’s Onyx Frontier DES Receives CE Mark Approval

August 24, 2022—Medtronic announced the European CE Mark approval and launch of the Onyx Frontier drug-eluting stent (DES) for the treatment of patients with coronary artery disease.

According to the company, the Onyx Frontier DES has an enhanced delivery system that builds on the acute performance of the previous-generation Resolute Onyx DES and is designed to improve deliverability by 16% without compromising on radial strength. Some of the new device design changes include a dual-layer balloon, a lower crossing profile, and increased catheter flexibility. The Onyx Frontier also offers a broad size matrix, ranging from 2- to 5-mm diameters. Its 4.5- to 5-mm sizes can be expanded to 6 mm to support extra-large vessels, noted the company.

Medtronic also stated in the announcement that the Onyx Frontier inherits the same clinical data and indications of Resolute Onyx, including approval for bifurcation lesions, left main percutaneous coronary intervention, and 1 month of dual antiplatelet therapy in high-bleeding-risk patients.

The recent European CE Mark approval comes after the DES was previously FDA approved in the United States in May 2022.

Jason Weidman, Senior Vice President and President of the Coronary & Renal Denervation business unit at Medtronic, stated in the announcement, “Following our launch in the United States, we’re thrilled to provide hospitals across western Europe and the globe with the Onyx Frontier DES, which has been thoughtfully designed with physicians’ needs in mind. This launch furthers Medtronic’s goal of engineering the extraordinary, and we look forward to continuing to pursue innovation each day.”