Onyx Frontier Drug-Eluting Stent Receives FDA Approval for CAD

The US Food and Drug Administration (FDA) has granted approval to Onyx Frontier drug-eluting stent (DES) for treatment of patients with coronary artery disease, according to a press release from Medtronic.

Announced on May 13, Onyx Frontier DES represents the latest iteration of Medtronic’s drug-eluting coronary stent system and the approval provides Onyx Frontier with the same clinical indications as Resolute Onyx, including the most recent approval for patients that are at high risk of bleeding who may benefit from a DAPT duration as short as one month.

"The new Onyx Frontier DES, with its enhanced deliverability, will continue to help interventional cardiologists treat complex coronary cases and larger ranges of vessel sizes more efficiently," said Azeem Latib, MD, section head of interventional cardiology and medical director of structural heart interventions at Montefiore Medical Center in New York City, in the aforementioned release. "Delivering safe and effective outcomes to our patients is our number one priority. It's important that physicians have access to tools like the Onyx Frontier DES that can allow them to efficiently achieve those outcomes."

According to Medtronic, the Onyx Frontier DES uses the same stent platform as the Resolute Onyx DES, but is designed with multiple changes, including increased catheter flexibility, an innovative dual-layer balloon technology and a lower crossing profile, which contributed to a 16% improvement in deliverability compared to Resolute Onyx. In their release, Medtronic noted the Onyx Frontier will be available in 2.0 mm sizes as well as 4.50-5.00 mm sizes that can be expanded to 6.00 mm.

The release from Medtronic also noted the Onyx Frontier DES is currently pending CE Mark from the European Medicines Agency.

"The Onyx Frontier DES FDA approval is a very important milestone for Medtronic's Coronary business and demonstrates our commitment to interventional cardiologists by providing best-in-class products," said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business at Medtronic, in the release. "The Onyx Frontier launch also correlates directly to Medtronic's commitment to engineering. The team built upon the design and clinical successes of the Resolute Onyx DES and has continued to evolve proven DES technology to further address the needs of physicians. We look forward to continuing the pursuit of innovation each day."