Image: Resolute Onyx DES helps meet all DES needs and many patient autonomies (Photo courtesy of Medtronic)
Coronary artery disease (CAD) is one of the leading causes of death and is caused by the buildup of plaque inside the coronary arteries. These plaque deposits can narrow or clog the inside of the arteries, decreasing the supply of blood and oxygen to the heart. To help restore blood flow, a doctor may use a stent (flexible metal scaffold) that is placed in a minimally invasive procedure to hold the artery open. A drug-eluting stent (DES) is the most common type of stent used to treat blockage in the heart arteries. Now, a new DES includes an improved delivery system designed to improve deliverability and increase acute performance, even in the most difficult cases.
The Onyx Frontier DES from Medtronic plc (Dublin, Ireland) for the treatment of patients with coronary artery disease is the latest evolution of the company’s Resolute DES family which offers an innovative delivery system and is based on the acute and clinical data for Resolute Onyx DES. Significant design changes including increased catheter flexibility, innovative dual-layer balloon technology, and a lower crossover profile have led to a 16% improvement in deliverability with Onyx Frontier compared to the previous generation Resolute Onyx DES .
In addition to delivery system enhancements, Onyx Frontier offers a large matrix to treat more patients and is the only 2.0 mm DES available in the United States (similar to Resolute Onyx). Additionally, Onyx Frontier continues to provide sizes from 4.50 to 5.00mm which can be extended to 6.00mm – specifically designed to support extra-large vessels. Onyx Frontier shares the same clinical indications as Resolute Onyx, including the most recent approval for patients at high risk of bleeding who may benefit from dual antiplatelet therapy (DAPT) for as short as one month. Medtronic has received US Food and Drug Administration (FDA) approval for DES Onyx Frontier and is awaiting CE (Conformité Européenne) marking.
“The Onyx Frontier DES FDA approval is a very significant 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 Medtronic’s cardiovascular portfolio. “The launch of Onyx Frontier is also directly linked to Medtronic’s commitment to engineering. The team built on the design and clinical successes of the Resolute Onyx DES and continued to evolve the proven DES technology to better meet the needs of physicians. We look forward to continuing the pursuit of innovation every day.”