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FDA approval for Onyx Frontier, the latest generation drug-eluting coronary stent system.- Medtronic

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Published:14th May 2022

The Onyx Frontier DES is used for the treatment of patients with coronary artery disease (CAD), which is caused by plaque buildup on the inside of the coronary arteries. These plaque deposits can narrow or clog the inside of the arteries, which decreases the supply of blood and oxygen to the heart. CAD is the leading cause of death for both men and women in the United States. To help to restore blood flow, a physician may use a stent (a flexible metal scaffolding) that is delivered during a minimally invasive procedure to prop open the artery. A drug-eluting stent is the most common type of stent used to treat a blockage of the heart arteries.

Meaningful design changes, including increased catheter flexibility, an innovative dual-layer balloon technology and a lower crossing profile led to a 16% improvement in deliverability with Onyx Frontier vs. the previous generation Resolute Onyx DES. In addition to the delivery system enhancements, Onyx Frontier offers a broad size matrix to treat more patients and is the only 2.0 mm DES available in the United States (similar to Resolute Onyx). Further, Onyx Frontier continues to provide 4.50-5.00 mm sizes that can be expanded to 6.00 mm - specifically designed to support extra-large vessels. Onyx Frontier shares the same clinical indications as Resolute Onyx, including the most recent approval for patients that are at high risk of bleeding who may benefit from a dual antiplatelet therapy (DAPT) duration as short as one month.

The Onyx Frontier DES is now approved in the United States and is pending CE (Conformité Européene) Mark.

Condition: Coronary Artery Disease
Type: drug

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