Medtronic’s Onyx Frontier DES Receives FDA Approval

May 13, 2022—Medtronic announced FDA approval for the company’s Onyx Frontier drug-eluting stent (DES) for the treatment of patients with coronary artery disease. The company advised that European CE Mark approval for the Onyx Frontier DES is pending.

According to Medtronic, the Onyx Frontier device builds on the same stent platform as the company’s Resolute Onyx DES and includes an enhanced delivery system designed to improve deliverability and increase acute performance in even the most challenging of cases. Onyx Frontier shares the same clinical indications as Resolute Onyx, including the most recent approval for patients who are at high risk of bleeding and who may benefit from a dual antiplatelet therapy duration as short as 1 month.

Design changes include increased catheter flexibility, dual-layer balloon technology, and a lower crossing profile, which have led to a 16% improvement in deliverability with Onyx Frontier versus the previous-generation Resolute Onyx DES, stated the company.

Onyx Frontier is available in a broad size matrix with diameters as small as 2 mm and as large as 4.5 to 5 mm that can be expanded to 6 mm—specifically designed to support extra-large vessels.

“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,” commented Azeem Latib, MD, in Medtronic’s press 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.” Dr. Latib is Section Head of Interventional Cardiology and Medical Director of Structural Heart Interventions at Montefiore Medical Center in New York, New York.