Medtronic Wins FDA Nod for Onyx Frontier DES

Medtronic said it has won FDA approval for the Onyx Frontier drug-eluting stent (DES). The Dublin-based company said the device is the latest evolution in the Resolute DES family.

The Onyx Frontier DES is used for the treatment of patients with coronary artery disease (CAD), which is caused by plaque buildup on the inside of the coronary arteries. These plaque deposits can narrow or clog the inside of the arteries, which decreases the supply of blood and oxygen to the heart. 

"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 & Renal Denervation business, which is part of the Cardiovascular Portfolio at Medtronic. "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."

Medtronic has hit some key milestones lately. The company recently closed on the $1.1 billion acquisition of Intersect ENT. To satisfy Federal Trade Commission concerns, Medtronic and Intersect ENT had to sell Fiagon to White Bear Lake, MN-based Hemostasis.