Dublin-based Medtronic plc is kicking off its pivotal U.S. study into the Resolute Onyx™ drug-eluting stent (DES) in patients who have coronary artery disease.
Based on its well-established Resolute Integrity DES, the Resolute Onyx DES features CoreWire Technology that allows it to have a denser core metal surrounded by a cobalt alloy outer layer. Medtronic claims the new technology not only enables the stent to have better radiopacity during the procedure, but 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 what Medtronic calls Continuous Sinusoid Technology (CST), a method of stent manufacturing first introduced with the Resolute Integrity DES, which molds one single strand of wire into a sinusoidal wave enabling a continuous range of motion. The device also features a new delivery system with PowerTrac™ technology that was introduced last year with the NC Euphora™ Noncompliant Balloon Dilatation Catheter.
The first phase of the U.S. clinical program will evaluate the Resolute Onyx in patients with small vessels that would require a 2.0 mm stent, which until now, often were untreatable with a DES. 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, M.D., 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 DES with CoreWire Technology is an exciting step forward in providing a treatment option for difficult-to-treat coronary lesions.”
“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.
Source: Medtronic plc