FDA approves Medtronic’s Resolute Onyx drug-eluting stent

Resolute Onyx

The FDA has approved Medtronic’s Resolute Onyx drug-eluting stent, which the company has now launched in the USA.

“As stent technologies continue to evolve, recent clinical studies have shown that newer technologies have not established a clinical advantage over durable polymer drug-eluting stent,” says Roxana Mehran, cardiologist and professor of medicine at Mount Sinai School of Medicine in New York City, USA. “The Resolute Onyx drug-eluting stent provides physicians with additional 4.5mm and 5mm sizes to treat patients with large coronary anatomies, while the stent’s enhanced visibility and excellent deliverability further differentiates it from other drug-eluting stents on the market.“

The Resolute Onyx is the first and only drug-eluting stent to feature the company’s Core Wire technology, an evolution of Continuous Sinusoid Technology (CST). CST 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 is intended to enable 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. The technology is designed to enable inner struts while maintaining structural strength.

The Resolute Onyx is designed with the transradial approach (through the wrist) in mind, including 5Fr catheter compatibility with stent sizes up to 5mm.

The Resolute Onyx drug-eluting stent is supported by the RESOLUTE ONYX Core (2.25mm-4mm) 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—designed for drug-eluting stent—that features a hydrophilic and hydrophobic blend intended to allow rapid endothelial healing with minimal inflammation and low risk of stent thrombosis.

The Resolute Onyx DES is available for use in the USA, as well as in Europe and other countries that recognise the CE mark.