www.fdanews.com/articles/209585-medtronic-gets-fda-approval-for-two-drug-eluting-stents
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.