The U.S. Food and Drug Administration has approved the Onyx Frontier drug-eluting stent (DES) to treat patients with coronary artery disease, the device manufacturer, Medtronic, announced today.
The Onyx Frontier shares the same stent platform and clinical indications as the previous-generation Resolute Onyx zotarolimus-eluting stent, including the most recent approval for patients at high risk of bleeding who may benefit from just 1 month dual-antiplatelet therapy.
“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,” Medtronic said in a news release.
Onyx Frontier also offers a broad size matrix to treat more patients, and joins the Resolute Onyx as the only 2-mm DES available in the United States, the company noted. The stent is available in 4.5- to 5-mm sizes that can be expanded to 6 mm, specifically designed to support extra-large vessels.
The Onyx Frontier DES is pending CE Mark in Europe.
A version of this article first appeared on Medscape.com.