FDA Approves New Medtronic Stent for Coronary Artery Disease

The US Food and Drug Administration (FDA) has approved drug-eluting stent (DES) Onyx Frontier, from Medtronic, for the treatment of patients with coronary artery disease (CAD).

The new DES product leverages the same platform as Medtronic’s Resolute Onyx, designed to improve the delivery of drugs and improve acute performance.

The company cited a 16% improvement in deliverability observed with Onyx Frontier versus the previous generation DES Resolute Onyx. Additionally, the new stent provides a 2.0 mm diameter, adding to stent size spectrum that ranges up to 6.0 mm for treated patients. The FDA indication granted to Onyx Frontier is the same as granted to Resolute Onyx, meaning it may be provided in care to patients who also may be at high risk of bleeding when treated with a dual antiplatelet therapy (DAPT) regimen for ≥1 month.

As the leading cause of death for both men and women in the US, CAD may be effectively treated with minimally-invasive application of a stent. The newest DES approval will benefit interventional cardiologists treating more complex cases with greater efficiency given the vessel size flexibility of the Onyx Frontier, Azeem Latib, MD, section head of interventional cardiology and medical director of structural heart interventions at Montefiore Medical Center, said in a statement.

"Delivering safe and effective outcomes to our patients is our number 1 priority,” Latib said in a statement. “It's important that physicians have access to tools like the Onyx Frontier DES that can allow them to efficiently achieve those outcomes."

Medtronic senior vice president and president of the Coronary & Renal Denervation business at Medtronic Jason Weidman, called the DES approval a “very important milestone” in the company’s coronary care venture.

“The Onyx Frontier launch also correlates directly to Medtronic's commitment to engineering,” Weidman said. “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."