Medtronic (NYSE:MDT) announced today that the FDA approved its Onyx drug-eluting stents (DES) for treating certain lesions.
Approval covers the treatment of non-left main bifurcation lesions utilizing the provisional bifurcation stenting technique. The technique uses a single stent to treat the bifurcation in percutaneous coronary interventions (PCIs). It applies to the FDA-approved and CE-marked Onyx Frontier and Resolute Onyx drug-eluting stents.
Medtronic said in a news release that the indication allows for a robust portfolio of medical education and procedural training for PCIs.
Bifurcation lesions often present unique challenges for cardiologists, Medtronic said. Attributes found in the company’s stents “optimize the treatment” of such lesions. The drug-eluting stents feature a single-wire design to provide vessel conformability and side branch access. The design also offers the option to open the stent cell while maintaining consistent stent scaffolding.
Medtronic cited clinical evidence from the Resolute Onyx bifurcation study supporting the stents. Resolute Onyx demonstrated low event rates, the company said. It beat the performance goal for the primary endpoint of target vessel failure at one year. The study results support the safety and efficacy of both stents in non-left main bifurcation lesions using the provisional stenting technique.
“The bifurcation expanded indication is yet another exciting milestone for our Coronary business this year,” said Jason Weidman, SVP and president of Medtronic’s Coronary & Renal Denervation business. “As the first and only medical device company to offer this indication to U.S. interventional cardiologists, Medtronic remains committed to investing in DES technology, clinical evidence, and physician education.
“We are looking forward to helping even more physicians access the tools they need to give their patients best-in-class care.”