FDA approves the Onyx Frontier drug-eluting stent (DES) and the Resolute Onyx DES to treat bifurcation percutaneous coronary intervention
Medtronic announced that it has received FDA approval for the treatment of non-left main bifurcation lesions utilizing the provisional bifurcation stenting technique (using a single stent to treat the bifurcation) with the Onyx Frontier drug-eluting stent (DES) and the Resolute Onyx DES
This indication will allow Medtronic to provide a robust portfolio of medical education and procedural training for physicians performing percutaneous coronary interventions (PCIs) in patients with bifurcation lesions.
The approval covers the use of a single Onyx Frontier and Resolute Onyx stent to treat non-left main bifurcation lesions, which occur when plaque accumulates around a division of a major coronary artery.
Researchers have found the one-device, provisional stenting method delivers better results than two stents in some patients, while physicians lacked a device specifically indicated by the FDA for the application.
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