Medtronic Launches Resolute Onyx Drug-Eluting Stent in United States
May 1, 2017—Medtronic announced the US Food and Drug Administration (FDA) approval and the United States launch of the Resolute Onyx drug-eluting stent (DES). The Resolute Onyx DES, which is designed for the transradial approach, includes 5-F–catheter compatibility with stent sizes up to 5 mm. The Resolute Onyx DES is available for use in the United States, as well as in Europe and other countries that recognize the CE Mark approval, advised the company.
Medtronic advised that the device's 4.5- and 5-mm sizes expand treatment options for patients with extra-large vessels. The Resolute Onyx DES builds on the performance and deliverability of the company's Resolute Integrity DES.
The Resolute Onyx DES's core wire technology is an evolution of Medtronic's continuous sinusoid technology, which is a method of stent manufacturing that involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent. This enables greater deliverability and conformability to the vessel wall.
With core wire technology, a radiopaque inner core is incorporated within the cobalt alloy wire to enhance visibility for accurate stent placement. Core wire technology also enables thinner struts while maintaining structural strength.
According to the company, the Resolute Onyx DES is supported by the RESOLUTE ONYX Core (2.25–4 mm) Clinical Study, as well as the long-term safety and efficacy with low stent thrombosis rates in the Global RESOLUTE clinical program. It uses the BioLinx polymer, which is specifically designed for DES. BioLinx features a unique hydrophilic and hydrophobic blend, allowing rapid endothelial healing with minimal inflammation and low risk of stent thrombosis.
In Medtronic's announcement, Roxana Mehran, MD, commented, “As stent technologies continue to evolve, recent clinical studies have shown that newer technologies have not established a clinical advantage over durable polymer DES. The Resolute Onyx DES provides physicians with additional 4.5- and 5-mm sizes to treat patients with large coronary anatomies, while the stent’s enhanced visibility and excellent deliverability further differentiate it from other DESs on the market.” Dr. Mehran is a cardiologist and Professor of Medicine at Mount Sinai School of Medicine in New York, New York.