U.S. Study for Medtronic Resolute Onyx Drug-Eluting Stent Begins

Medtronic plc has kicked off a clinical evaluation in the United States of its Resolute Onyx drug-eluting stent (DES) in patients with coronary artery disease. Included in the first phase of the study are patients with small vessels that would require a 2-millimeter stent, which until now, often were untreatable with a DES.

Core sizes of the stent will be studied separately, study officials said.

“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, M.D., cardiologist and professor of medicine at Mount Sinai School of Medicine in New York, N.Y., and principal investigator for the study. “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.”

The Resolute Onyx DES includes Medtronic’s CoreWire Technology that allows it to have a denser core metal surrounded by a cobalt alloy outer layer. The new technology enables the stent to have better radiopacity (visibility) during the procedure, as well as thinner struts. This means the stent is designed to help improve deliverability without compromising radial and longitudinal strength, all of which help improve the efficiency of procedures, according to the company.

CoreWire Technology builds on Continuous Sinusoid Technology (CST), a method of stent manufacturing first introduced with Medtronic’s Resolute Integrity DES, which molds 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 optimizes 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 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.”

Resolute Onyx DES also features a new delivery system.

The Resolute Onyx DES received CE mark in November last year. The Resolute Onyx DES is not available for use in the United States outside of the clinical trial.

Medtronic is based in Dublin, Ireland.