Medtronic initiates pivotal studies of Resolute Onyx drug-eluting stent in USA


Medtronic has announced the start of its Resolute Onyx Clinical Program in the United States, which will evaluate the Resolute Onyx drug-eluting stent in patients with coronary artery disease. Included in the first phase of the study are patients with small vessels that would require a 2mm stent, which until now, often were untreatable with a drug-eluting stent. Core sizes of the stent will be studied separately.

“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,” said Roxana Mehran, cardiologist and professor of medicine at Mount Sinai School of Medicine in New York City, and principal investigator for the study. “The trial initiation of the Resolute Onyx with CoreWire Technology is an exciting step forward in providing a treatment option for difficult-to-treat coronary lesions.”

Built on the proven clinical performance and superior deliverability of the Resolute Integrity drug-eluting stent, the Resolute Onyx features CoreWire Technology giving it a denser core metal surrounded by a cobalt alloy outer layer. The new technology enables the stent to have better radiopacity during the procedure, and with thinner struts, the stent is designed to help improve deliverability without compromising radial and longitudinal strength, all of which help improve the efficiency of procedures.

CoreWire Technology builds on Continuous Sinusoid Technology, a method of stent manufacturing first introduced with the Resolute Integrity drug-eluting stent, which moulds one single strand of wire into a sinusoidal wave enabling a continuous range of motion.

“CoreWire Technology represents a new foundation for drug-eluting stent innovation that optimises the treatment of coronary artery disease,” said Jason Weidman, vice president and general manager of the coronary business at Medtronic. “With approval to begin studying this device in the USA, we hope to demonstrate how this technological advancement enables the Resolute Onyx to become a workhorse device for US physicians that can increase procedural efficiency and enhance deliverability in a broad range of vessel sizes.”

Resolute Onyx also features a new delivery system with PowerTrac technology that was introduced last year with the NC Euphora noncompliant balloon dilatation catheter.

Resolute Onyx received CE mark in November 2014 and is available for use in countries that recognise the CE mark. It is not available for use in the USA outside of this clinical programme.