Medtronic Announces FDA Clearance, Product Launch For Resolute Onyx Drug-Eluting Stent

Medtronic plc announced the U.S. Food and Drug Administration (FDA) approval and U.S. launch of the Resolute Onyx Drug-Eluting Stent (DES). The Resolute Onyx DES builds on the proven clinical performance and superior deliverability of the Resolute Integrity DES to further strengthen the gold standard safety and efficacy of DES technology.

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“As stent technologies continue to evolve, recent clinical studies have shown that newer technologies have not established a clinical advantage over durable polymer DES,” says Roxana Mehran, MD, cardiologist and professor of medicine at Mount Sinai School of Medicine in New York City. “The Resolute Onyx DES provides physicians with additional 4.5 mm and 5.0 mm sizes to treat patients with large coronary anatomies, while the stent’s enhanced visibility and exceptional deliverability further differentiates it from other drug-eluting stents on the market.”

The Resolute Onyx DES is the first and only DES to feature Core Wire Technology, an evolution of Continuous Sinusoid Technology (CST). CST is a unique Medtronic method of stent manufacturing, which 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.

The Resolute Onyx DES is designed with the transradial approach (through the wrist) in mind, including 5 Fr catheter compatibility with stent sizes up to 5.0 mm. With the first 4.5 mm and 5.0 mm DES sizes available in the U.S., the Resolute Onyx DES helps expand treatment options for patients with extra-large vessels.

“We set out to expand upon a proven DES technology to enhance clinical performance and deliver further meaningful innovations that address the needs of interventional cardiologists around the globe,” says Jason Weidman, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic. “Already making a significant impact outside of the U.S., the Resolute Onyx DES with Core Wire Technology exemplifies our commitment to advancing our DES portfolio by combining cutting-edge engineering with proven components for a wide range of patients.”

The Resolute Onyx DES is supported by the RESOLUTE ONYX Core (2.25mm-4.0mm) 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— specifically designed for DES—that features a unique hydrophilic and hydrophobic blend, allowing rapid endothelial healing with minimal inflammation and low risk of stent thrombosis

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.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.