Medtronic’s Latest Generation Drug-Eluting Coronary Stent System Offers Dual-Layer Balloon Technology

Coronary artery disease (CAD) is one of the leading causes of death and 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. To help to restore blood flow, a physician may use a stent (flexible metal scaffolding) that is delivered during a minimally invasive procedure to prop open the artery. A drug-eluting stent (DES) is the most common type of stent used to treat a blockage of the heart arteries. Now, a new DES features an enhanced delivery system designed to improve deliverability and increase acute performance in even the most challenging of cases.

The Onyx Frontier DES from Medtronic plc (Dublin, Ireland) for the treatment of patients with CAD is the latest evolution in the company’s Resolute DES family that offers an innovative delivery system and builds upon the acute performance and clinical data from the Resolute Onyx DES. Meaningful design changes, including increased catheter flexibility, an innovative dual-layer balloon technology and a lower crossing profile led to a 16% improvement in deliverability with Onyx Frontier vs. the previous generation Resolute Onyx DES.

In addition to the delivery system enhancements, Onyx Frontier offers a broad size matrix to treat more patients and is the only 2.0 mm DES available in the US (similar to Resolute Onyx). Further, Onyx Frontier continues to provide 4.50-5.00 mm sizes that can be expanded to 6.00 mm - specifically designed to support extra-large vessels. Onyx Frontier shares 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 dual antiplatelet therapy (DAPT) duration as short as one month. Medtronic has received U.S. Food and Drug Administration (FDA) approval for the Onyx Frontier DES and is awaiting the CE (Conformité Européene) Mark.

"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."

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