Nov. 13, 2014 — Optimizing the treatment of coronary artery disease with a new foundation for future stent innovations, Medtronic Inc. announces CE mark and international launch of the Resolute Onyx Drug-Eluting Stent (DES). The first live patient implant of the Resolute Onyx DES occurred recently during the XII International Course of Endovascular and Myocardial Therapy in Madrid, Spain. The Resolute Onyx Drug-Eluting Stent is not approved in the United States.
Built on the proven clinical performance and deliverability of the Resolute Integrity DES, the Resolute Onyx DES is the first stent to feature a new advancement called CoreWire Technology that allows it to have a denser core metal wrapped in a cobalt alloy outer layer. This new technology enables increased radiopacity (i.e., visibility during the procedure) and the Resolute Onyx DES has thinner struts to help improve deliverability without compromising radial and longitudinal strength.
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. The advanced delivery system provides superior and enhanced deliverability through challenging lesions.
CoreWire Technology is the next new DES advancement after Continuous Sinusoid Technology (CST), which was previously introduced with the Resolute Integrity DES and the Integrity bare-metal stent. CST is a method of stent manufacturing that molds one single strand of wire into a sinusoidal wave enabling a continuous range of motion.
Available in a broad size matrix (including a new 2.0 mm diameter), the CE mark labeling for Resolute Onyx DES includes information on one 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 one month. While physicians should continue to adhere to current ESC or ACC/AHA/SCAI guidelines for PCI, patients who interrupt or discontinue DAPT medication one month or more after stent implantation are considered at low risk and showed no increased risk for stent thrombosis.”
Resolute Onyx expands Medtronic’s interventional cardiology portfolio of medical devices across Coronary, Renal Denervation and TAVI, and is the latest in a series of 12 new product introductions planned over the next two years.
The Resolute Onyx DES is now available in select countries that recognize the CE mark.
In collaboration with leading clinicians, researchers and scientists, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.
For more information: www.medtronic.com