Medtronic’s Onyx Frontier and Resolute Onyx DESs Receive Approval for Bifurcation Indication

September 21, 2022—Medtronic announced FDA approval for the treatment of non–left main bifurcation lesions using the provisional bifurcation stenting technique with the Onyx Frontier drug-eluting stent (DES) and the Resolute Onyx DES.

The indication will allow Medtronic to provide a portfolio of medical education and procedural training for physicians performing percutaneous coronary interventions (PCIs) in patients with bifurcation lesions. Medtronic advised that both the Onyx Frontier and Resolute Onyx DESs are FDA and CE Mark approved.

According to the company, the devices feature a single-wire design, which allows for the optimized treatment of complex bifurcation anatomy by providing excellent vessel conformability, easier side branch access, and the option to open the stent cell while maintaining consistent stent scaffolding.

Use of the Onyx Frontier and Resolute Onyx DES in this indication is backed by clinical evidence from the Resolute Onyx Bifurcation study. The study’s findings support the safety and efficacy of both devices in non–left main bifurcation lesions using the provisional stenting technique. The Resolute Onyx DES demonstrated low event rates, beating the performance goal for the primary endpoint of target vessel failure at 1 year, noted Medtronic.