Ireland-based Medtronic's Resolute Onyx drug-eluting stent (DES) has received approval from the US Food and Drug Administration (FDA).

Based on the performance and deliverability of the Resolute Integrity DES, the new device is designed to improve the safety and efficacy of DES technology.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The new tool is available in sizes 4.5mm and 5mm to allow physicians to treat patients with large coronary anatomies.

It features core wire technology, which is an upgraded version of the firm’s continuous sinusoid technology method for manufacturing stents that involves the formation of a single strand of cobalt alloy wire into a sinus.

Core Wire Technology enables incorporation of a radiopaque inner core within the cobalt alloy wire for better visibility, and thinner struts to maintain structural strength.

"The Resolute Onyx DES exemplifies our commitment to advancing our DES portfolio by combining cutting-edge engineering with proven components for a wide range of patients."

Medtronic Coronary and Renal Denervation business vice-president and general manager Jason Weidman said: “We set out to enhance clinical performance and deliver further meaningful innovations that address the needs of interventional cardiologists around the globe.

“The Resolute Onyx DES exemplifies our commitment to advancing our DES portfolio by combining cutting-edge engineering with proven components for a wide range of patients.”

The FDA approval is based on the Resolute Onyx Core (2.25mm-4.0mm) clinical study, as well as the long-term safety and efficacy data that showed low stent thrombosis rates.

The Resolute Onyx DES also includes the BioLinx polymer with a hydrophilic and hydrophobic blend to facilitate endothelial healing, reduce inflammation and lower the risk of stent thrombosis.

Image: Resolute Onyx DES. Photo: courtesy of Medtronic.