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Medtronic Gets FDA Approval for Two Drug-Eluting Stents

September 29, 2022

Medtronic has received FDA’s approval for its Onyx Frontier and Resolute Onyx drug-eluting stents that use a single-wire design.

The devices have been approved to treat non-left main bifurcation lesions that occur when plaque builds up around the junction of two coronary arteries.

The open-cell stents allow for easier side branch access while maintaining a consistent stent scaffolding.

Based on the new indication, Medtronic plans to provide a “robust portfolio of medical education and procedural training for physicians” for treating bifurcation lesions, the company said.

Both devices previously earned CE mark certifications.

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