Medtronic launches Resolute Onyx drug-eluting stent following CE mark approval


Medtronic has undertaken the international launch of its Resolute Onyx drug-eluting stent following the receipt of CE mark approval. The first live patient implant of the Resolute Onyx occurred during the XII International Course of Endovascular and Myocardial Therapy in Madrid, Spain.

“Following my experience with the Resolute Onyx drug-eluting stent, I’ve been able to see first-hand how the CoreWire technology offers improved deliverability in complex lesions, enhanced conformability to the vessel wall and greater radiopacity for more accurate stent placement,” says Eulogio Garcia, an interventional cardiologist at the Hospital Universitario Clínico San Carlos, Madrid, Spain, who performed the first implant of the device.

Built on the proven clinical performance and superior deliverability of the Resolute Integrity drug-eluting stent, the Resolute Onyx 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 and the Resolute Onyx has thinner struts to help improve deliverability without compromising radial and longitudinal strength.

The Resolute Onyx drug-eluting stent 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 drug-eluting stent advancement after continuous sinusoid technology, which was previously introduced with the Resolute Integrity drug-eluting stent and the Integrity bare-metal stent. Continuous sinusoid technology is a method of stent manufacturing that moulds one single strand of wire into a sinusoidal wave enabling a continuous range of motion.

“CoreWire Technology is an exciting innovation that will have measurable impact on clinical practice today and tomorrow,” says Jason Weidman, vice president and general manager of the coronary and renal denervation business unit at Medtronic. “The advancements of the Resolute Onyx drug-eluting stent specifically address the need for continued procedural efficiency and ease-of-use. Importantly, and in contrast to some current drug-eluting stent technologies, it achieves meaningful deliverability enhancement with no compromise to stent strength.”

Available in a broad size matrix (including a new 2.0mm diameter), the CE-mark labelling for Resolute Onyx drug-eluting stent includes information on one month of dual antiplatelet therapy. The labelling states: “One year data from the Global RESOLUTE Program indicates low stent thrombosis rates for those who interrupted or discontinued dual antiplatelet therapy 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 dual antiplatelet therapy medication one month or more after stent implantation are considered at low risk and showed no increased risk for stent thrombosis.”