FDA gives a nod to Medtronic’s Resolute Onyx Drug Eluting Coronary Stent

Medtronic plc, a leading medical device company, recently declared about the approval given by Food and Drug Administration to its Resolute Onyx™ Drug-Eluting Stent. This new device is based on the already proven superior deliverability and clinical performance of the Resolute Integrity™ Drug-Eluting Stent to further enhance the gold standard efficacy and safety of drug-eluting stent technology.

Professor, Mount Sinai School of Medicine, New York City, Roxana Mehran, said, “As stent technologies endure to advance, latest clinical studies have demonstrated that newer technologies haven’t noted a clinical benefit over the durable polymer drug-eluting stent. The Resolute Onyx DES offers the physicians with additional 5.0 mm and 4.5 mm sizes to operate patients with big coronary anatomies. Further, the exceptional deliverability and improved visibility of the stent distinguishes it from the other drug-eluting stents available in the market.”

The new device is the first and only drug-eluting stent to present Core Wire Technology, an advancement of Continuous Sinusoid Technology. It is an exclusive Medtronic process of manufacturing a stent, which consists of making a single thread of cobalt alloy wire into a sinusoidal wave to build a stent. This provides better conformability and deliverability to the wall of the vessel. With Core Wire Technology, to improve the visibility for the appropriate placing of the stent, a radiopaque inner core is integrated within the cobalt alloy wire. The Core Wire Technology also allows thinner struts while retaining structural strength.

With the first 5.0 mm and 4.5 mm drug-eluting stent sizes obtainable in the United States, the new device helps in extending the treatment alternatives for patients with larger vessels. The Resolute Onyx drug-eluting stent is supported by the low stent thrombosis rates coupled with long-term efficacy and safety in the Global RESOLUTE Clinical Program as well as the RESOLUTE ONYX Core (2.25–4.0 mm) Clinical Study. It utilizes the BioLinx™ polymer, which is particularly developed for the drug-eluting stent, featuring a unique hydrophobic and hydrophilic blend, facilitating fast endothelial curing with low stent thrombosis risk and minimum inflammation.

The Resolute Onyx drug-eluting stent is accessible for use in the United States, Europe as well as other countries that have received a CE Mark.