Medtronic gains FDA approval for Onyx Frontier drug-eluting stent

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Medtronic has announced that it has received US Food and Drug Administration (FDA) approval for the Onyx Frontier drug-eluting stent (DES).

Onyx Frontier is the latest generation in Medtronic’s Resolute range of devices, and according to Medtronic, features an enhanced delivery system designed to improve deliverability and increase acute performance in challenging of cases.

The Onyx Frontier DES is used for the treatment of patients with coronary artery disease (CAD), which is caused by plaque build-up on the inside of the coronary arteries.

“The new Onyx Frontier DES, with its enhanced deliverability, will continue to help interventional cardiologists treat complex coronary cases and larger ranges of vessel sizes more efficiently,” said Azeem Latib (Montefiore Medical Center, New York, USA). “Delivering safe and effective outcomes to our patients is our number one priority. It is important that physicians have access to tools like the Onyx Frontier DES that can allow them to efficiently achieve those outcomes.”

In a press release, Medtronic adds that design changes incorporated in the Onyx Front include increased catheter flexibility, a dual-layer balloon technology and a lower crossing profile, which have led to a 16% improvement in deliverability with Onyx Frontier versus 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 2mm DES available in the USA (similar to Resolute Onyx),” Medtronic’s press release adds. Onyx Frontier is available in 4.5-5mm sizes that can be expanded to 6.00 mm, and 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 USA and is pending CE mark.


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