Medtronic Initiates United States Pivotal Study of Resolute Onyx DES

March 12, 2015—Medtronic plc announced the start of its Resolute Onyx clinical program in the United States, which will evaluate the Resolute Onyx drug-eluting stent (DES) in patients who have coronary artery disease. The first phase of the study will include patients with small vessels that would require a 2-mm stent. The company noted that the stent size is a potential option to treat these patients who are often untreatable with a DES. Core sizes of the stent will be studied separately.

According to Medtronic, the Resolute Onyx DES features the company’s CoreWire technology that allows it to have a denser core metal surrounded by a cobalt alloy outer layer. The technology enables the stent to have better radiopacity during the procedure, and its thinner struts help improve deliverability without compromising radial and longitudinal strength. The CoreWire technology builds on continuous sinusoid technology, a method of stent manufacturing introduced with Medtronic’s Resolute Integrity DES. Continuous sinusoid technology molds a single strand of wire into a sinusoidal wave, enabling a continuous range of motion.

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

In Medtronic’s press release, Principal Investigator Roxana Mehran, MD, commented, “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. 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 received European CE Mark approval in November 2014 and is available for use in countries that recognize the CE Mark. The Resolute Onyx DES is not available for use in the United States outside of this clinical program, advised Medtronic.