Medtronic (NYSE:MDT) said it won CE Mark approval in the European Union for its Resolute Onyx drug-eluting stent, made using its new CoreWire technology.
The Resolute Onyx devices is based on Medtronic’s Resolute Integrity DES, but uses the CoreWire technique to wrap a cobalt alloy around a denser metal to increase radiopacity and allow for thinner struts, according to a press release.
The new stent also uses a new delivery catheter, the PowerTrac device introduced earlier this year with the NC Euphora drug-eluting balloon, Medtronic said.
"CoreWire technology is an exciting innovation that will have measurable impact on clinical practice today and tomorrow," coronary & renal denervation general manager Jason Weidman said in prepared remarks. "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."
"Following my experience with the Resolute Onyx DES, 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," added Dr. Eulogio Garcia, who performed the 1st Resolute Onyx implantation at Madrid’s Hospital Universitario Clínico San Carlos.