Medtronic Awarded FDA Approval For Bifurcation Lesion Medical Devices

Medtronic has become the first company to receive the U.S. Food and Drug Administration’s (FDA) approval for their Onyx Frontier and Resolute Onyx drug-eluting stents used for bifurcation percutaneous coronary intervention. With FDA approval, Medtronic will be able to offer a wide range of medical training and technical assistance to physicians using percutaneous coronary interventions to treat patients with bifurcation lesions.

Bifurcation lesions occur when plaque accumulates at the meeting point of two coronary arteries. As a result of the structural changes in the arteries and the difficulty in obtaining access to the side branches, the lesions are often regarded as being difficult to treat. Bifurcation lesions are frequently linked to lower successful outcomes and increased rates of long-term unfavorable cardiac events. Stent attributes like the Onyx Frontier are essential to bifurcation lesion treatment as the condition frequently presents patient-specific challenges for interventional cardiologists. Medtronic believes that the single-wire structure of their stents makes them ideal for bifurcation lesions treatment. 

The manufacturer claims their products are a good fit for intricate bifurcation anatomy and enable physicians to access side branches since a single strand of wire is shaped into a wave to form the stent. “This design 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.” In a clinical trial which tested the devices on 205 patients, the devices demonstrated low event rates to achieve the performance goal. The encouraging findings indicate that the stents are safe and effective for bifurcation lesion treatment. 

“The bifurcation expanded indication is yet another exciting milestone for our Coronary business this year,” said Medtronic’s Jason Weidman. “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.”