FDA Clears Medtronic's Resolute Onyx Drug-Eluting Stent

Patrice Wendling

May 01, 2017

DUBLIN, IRELAND — The US Food and Drug Administration today approved a new drug-eluting stent (DES) for the treatment of coronary artery disease, according to the device manufacturer[1].

The Resolute Onyx DES (Medtronic) is manufactured by molding a single strand of cobalt alloy wire into a sinusoidal wave. This offers greater deliverability and conformability to the vessel wall, while a radiopaque inner core incorporated into the cobalt wire enhances visibility during stent placement, the company explained in a news release.

"The Resolute Onyx DES provides physicians with an additional 4.5-mm and 5.0-mm sizes to treat patients with large coronary anatomies, while the stent's enhanced visibility and excellent deliverability further differentiates it from other drug-eluting stents on the market," Dr Roxana Mehran (Mount Sinai School of Medicine, New York, NY) said in the release.

The company said the stent is designed with the transradial approach in mind and has 5 Fr catheter compatibility.

The zotarolimus-eluting stent has been available for years in Europe, after receiving CE mark approval in November 2014.

US approval of the Resolute Onyx DES is based on results of the Resolute Onyx Core clinical study and the Global Resolute clinical program, which showed low rates of stent thrombosis.

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