Medtronic Launches Resolute Onyx DES After CE Mark Approval

November 3, 2014—Medtronic, Inc. announced European CE Mark approval and the international launch of the Resolute Onyx drug-eluting stent (DES). The Resolute Onyx DES is now available in select countries that recognize the CE Mark. The device is not approved in the United States, noted the company.

Eulogio Garcia, MD, an interventional cardiologist at the Hospital Universitario Clínico San Carlos in Madrid, Spain, recently performed the first implantation of the Resolute Onyx DES during the XII International Course of Endovascular and Myocardial Therapy in Madrid, Spain.

In the company’s press release, Dr. Garcia commented, “Following my experience with the Resolute Onyx DES, I've been able to see firsthand how the CoreWire technology offers improved deliverability in complex lesions, enhanced conformability to the vessel wall, and greater radiopacity for more accurate stent placement.”

The Resolute Onyx DES, which is available in a broad size matrix including a new 2-mm diameter, is built on the proven clinical performance and deliverability of the Resolute Integrity DES. The Resolute Onyx DES features the company’s CoreWire technology that allows it to have a denser core metal wrapped in a cobalt alloy outer layer. This new technology enables increased radiopacity, and the Resolute Onyx DES has thinner struts to help improve deliverability without compromising radial and longitudinal strength. The Resolute Onyx DES features a new delivery system with PowerTrac technology that was introduced earlier this year with the NC Euphora noncompliant balloon dilatation catheter.

CoreWire technology is the next new DES advancement after continuous sinusoid technology, which was previously introduced with the Resolute Integrity DES and the Integrity bare-metal stent. Continuous sinusoid technology is a method of stent manufacturing that molds one single strand of wire into a sinusoidal wave, enabling a continuous range of motion.

The CE Mark labeling for Resolute Onyx DES includes information on 1 month of dual-antiplatelet therapy (DAPT). The labeling states: “One-year data from the Global RESOLUTE Program indicates low stent thrombosis rates for those who interrupted or discontinued DAPT any time after 1 month. While physicians should continue to adhere to current European Society of Cardiology or American College of Cardiology/American Heart Association/Society for Cardiac Angiography and Interventions guidelines for percutaneous coronary interventions, patients who interrupt or discontinue DAPT medication 1 month or more after stent implantation are considered at low risk and showed no increased risk for stent thrombosis.”