Medtronic Onyx Frontier Drug-eluting Stent OK’d

FDA has approved a Medtronic PMA for the Onyx Frontier drug-eluting stent (DES), indicated for treating patients with coronary artery disease, which is caused by plaque buildup on the inside of the coronary arteries. The device is designed to improve deliverability and will “continue to help interventional cardiologists treat complex coronary cases and larger ranges of vessel sizes more efficiently,” the company says.

Meaningful design changes include increased catheter flexibility, a dual-layer balloon technology and a lower crossing profile, which led to a 16% improvement in deliverability with Onyx Frontier vs. the previous generation Resolute Onyx DES, Medtronic says. “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,” it says.