Irish medical technology firm Medtronic has commenced the Resolute Onyx Clinical Program in the US, which is designed to assess the Resolute Onyx drug-eluting stent (DES) in patients with coronary artery disease.
The first phase of the trial includes patients with small vessels that would require a 2mm stent, who were currently untreatable with a DES. The core sizes of the stent will be studied separately.
New York City’s Mount Sinai School of Medicine medicine professor and cardiologist and study principal investigator Dr Roxana Mehran 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."
Medtronic coronary business general manager and vice president Jason Weidman said: "With approval to begin studying this device in the US, we hope to demonstrate how this technological advancement enables the Resolute Onyx DES to become a workhorse device for US physicians that can increase procedural efficiency and enhance deliverability in a broad range of vessel sizes."
The Resolute Onyx DES features CoreWire Technology that enables it to have a denser core metal surrounded by a cobalt alloy outer layer, a new delivery system with PowerTrac technology that was launched last year with the NC Euphora Noncompliant Balloon Dilatation Catheter.
Build on Continuous Sinusoid Technology (CST), the CoreWire Technology will help the stent to have better radiopacity (visibility) during the procedure.
In November last year, the Resolute Onyx DES received CE mark approval, and is currently not available for use in the US outside of this clinical program.