Medtronic is 'Resolute' to Strut its DES Stuff

The company's Resolute Onyx drug-eluting stent was among the hottest devices expected to hit the U.S. market in 2017.

Amanda Pedersen

Medtronic's Resolute Onyx DES features the company's new Core Wire Technology, which is intended to enhance visibility for accurate stent placement.

Medtronic appears to be resolute to strengthen its position in the drug-eluting stent (DES) market. The company snagged FDA approval for its Resolute Onyx DES, which has been dubbed one of the hottest devices expected to hit the U.S. market this year.

The new stent, which received CE mark approval in November 2014, was designed to build on the earlier Resolute Integrity DES.

"As stent technologies continue to evolve, recent clinical studies have shown that newer technologies have not established a clinical advantage over durable polymer DES," said Roxana Mehran, a cardiologist and professor of medicine at Mount Sinai School of Medicine in New York. "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 excellent deliverability further differentiates it from other drug-eluting stents on the market."

The new stent is the first to feature the company's new Core Wire Technology, an evolution of its Continuous Sinusoid Technology (CST). CST is Medtronic's stent manufacturing method that involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent. With the Core Wire Technology, a radiopaque inner core is incorporated within the cobalt alloy wire to enhance visibility for accurate stent placement, the company said. Core Wire Technology also enables thinner struts, while maintaining structural strength, according to Medtronic.

The Resolute Onyx DES was 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 United States, the Resolute Onyx DES helps expand treatment options for patients with extra-large vessels, the company said.

"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," said 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.

FDA approval of the Resolute Onyx DES was supported by the RESOLUTE ONYX Core study, along with the long-term safety and efficacy with low stent-thrombosis rates in Medtronic's global RESOLUTE clinical program.

The new stent uses the BioLinx polymer, which was specifically designed for drug eluting stents and features a hydrophilic and hydrophobic blend, intended to allow rapid endothelial healing with minimal inflammation and a low risk of stent thrombosis.

Click here to see Qmed's full list of 10 hot devices anticipated in 2017.

Amanda Pedersen is Qmed's news editor. Contact her at [email protected].

[Image credit: Medtronic plc]