The Resolute Onyx device is based on Medtronic’s Resolute Integrity DES, but uses the Fridley, Minn.-based firm’s new CoreWire technology to wrap a cobalt alloy around a denser metal to increase radiopacity and allow for thinner struts, according to a press release.
Medtronic said the 1st phase of the study will include patients with small vessels requiring a 2.0mm stent, with core sizes of the Resolute Onyx stent to be studied separately.
"CoreWire technology represents a new foundation for drug-eluting stent innovation that optimizes the treatment of coronary artery disease," coronary & renal denervation general manager Jason Weidman said in prepared remarks. "With approval to begin studying this device in the United States, we hope to demonstrate how this technological advancement enables the Resolute Onyx DES to become a workhorse device for U.S. physicians that can increase procedural efficiency and enhance deliverability in a broad range of vessel sizes.”
“One of the biggest challenges we face as interventional cardiologists is treating small, diseased coronary arteries – a common condition seen frequently in patients with diabetes," added principal investigator Dr. Roxana Mehran of New York City’s Mount Sinai School of Medicine. "The trial initiation of the Resolute Onyx DES with CoreWire technology is an exciting step forward in providing a treatment option for difficult-to-treat coronary lesions."
Medtronic said last November that it won CE Mark approval in the European Union for the Resolute Onyx device.