Medtronic launches Onyx Frontier coronary stent following CE mark approval

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Medtronic has announced the launch of its latest generation drug-eluting coronary stent—Onyx Frontier—following recent CE mark approval.

In a press release, Medtronic detailed that Onyx Frontier leverages the same stent platform as the Resolute Onyx drug-eluting stent (DES), with an enhanced delivery system “designed to improve deliverability and increase acute performance in the most challenging cases”.

Design changes incorporated in the latest generation device include a dual-layer balloon, lower crossing profile, and increased catheter flexibility leading to a 16% improvement in deliverability versus the previous generation Resolute Onyx DES without compromising on radial strength, Medtronic’s press release states.

Onyx Frontier offers a broad size matrix to treat patients ranging from 2mm to 5mm diameters and its 4.50-5mm sizes can be expanded to 6mm—specifically designed to support extra-large vessels including the left main. Onyx Frontier inherits the same clinical data and indications of Resolute Onyx, including approval for bifurcation lesions, left main percutaneous coronary intervention (PCI), and one month of dual antiplatelet therapy (DAPT) in high bleeding risk patients.

“The Onyx Frontier DES launch demonstrates our commitment to interventional cardiologists by providing best-in-class products,” said Jason Weidman, senior vice president and president of the Coronary & Renal Denervation business unit, which is part of the Cardiovascular Portfolio at Medtronic. “Following our launch in the USA, we are 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.”

The Onyx Frontier DES received US Food and Drug Administration (FDA) approval in the USA in May and recently received CE mark in Europe.


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