Medtronic ($MDT) kicked off the commercialization of its Resolute Onyx drug-eluting stent in Europe today. The device will also be launched in selected countries around the world that recognize the CE mark, but not the U.S., where FDA approval is required.
The features of the CE-marked stent include increased radiopacity, enabling visibility during the procedure, and thinner struts to improve deliverability without a decrease in strength, Medtronic said. It said the new advancements are a result its CoreWire Technology.
"CoreWire Technology is an exciting innovation that will have measurable impact on clinical practice today and tomorrow," said Jason Weidman, vice president of the company's coronary and renal denervation business unit, in a statement. "The advancements of the Resolute Onyx DES specifically address the need for continued procedural efficiency and ease-of-use. Importantly, and in contrast to some current DES technologies, it achieves meaningful deliverability enhancement with no compromise to stent strength."
The product consists of metal wrapped in a cobalt alloy outer layer, according to the statement. It also uses a new delivery system first employed in conjunction with the NC Euphora Noncompliant Balloon Dilatation Catheter and uses a stent manufacturing method dubbed Continuous Sinusoid Technology. The method involves molding a single strand of wire. It was used on the previous generation Resolute Integrity drug eluting stent as well as the Integrity bare metal stent, according to Medtronic.
Resolute Onyx is available in a variety of diameters, including 2 millimeters, Medtronic says. The company plans 12 new product launches over the next 2 years, in arenas such as coronary conditions, TAVR/TAVI and renal denervation.
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