Receive our newsletter – data, insights and analysis delivered to you
  1. News
May 2, 2017

Medtronic’s Resolute Onyx DES secures FDA approval

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

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.

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.

Content from our partners
The added value of Qarad’s multilingual freephone service to their eIFU solution
Small and simple: how medical device manufacturers select materials
Precision wire: The future of bespoke medical treatment

“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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU