Medtronic (NYSE:MDT) announced today that it received FDA approval for its Onyx Frontier drug-eluting stent (DES).
Onyx Frontier, the latest iteration of Medtronic’s Resolute DES family, was designed to leverage the same stent platform as Resolute with an enhanced delivery system for improving deliverability and increasing acute performance, even in the most challenging of cases.
The stent was designed to treat patients with coronary artery disease (CAD), according to a news release. A physician delivers the stent through a minimally invasive procedure to prop open the artery to treat a blockage of heart arteries.
Onyx Frontier features increased catheter flexibility, an innovative dual-layer balloon technology and a lower crossing profile. It offers a broad size matrix to treat more patients, with Medtronic saying it is the only 2 mm DES available in the U.S. It also comes in 4.5-5 mm sizes that can be expanded to 6 mm to support extra-large vessels.
The platform shares the same clinical indications as the Resolute Onyx, including for patients at high risk of bleeding who may benefit from a dual antiplatelet therapy (DAPT) duration as short as one month.
Medtronic said the now FDA-approved Onyx Frontier is currently pending CE mark approval.
“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,” Medtronic SVP and President of its Coronary and Renal Denervation business Jason Weidman said 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.”