Following FDA approval, Resolute Onyx 2mm becomes smallest stent on US market

A cross-section of Medtronic’s Resolute Onyx Core Wire technology

Designed specifically for small vessels, the Resolute Onyx 2mm drug-eluting stent has received US FDA approval and, consequently, has been launched on to the US market. According to a press release, the device is now the smallest sized drug-eluting stent on the US market. It is designed to help interventional cardiologists treat patients with coronary artery disease who have small vessels—which are often untreatable with larger stent technologies during percutaneous coronary intervention (PCI).

The first—and only—2mm drug-eluting stent size available in the USA, the press release reports, the newly approved stent joins the Resolute Onyx 4.5mm and 5mm drug-eluting stents to provide physicians  with the broadest drug-eluting stent size matrix available. The press release state that the Resolute range of device means that there are options for treating patients with the smallest coronary vessels to the largest, from the simplest of anatomies to the complex. Additionally, the stent is engineered with the lowest crossing profile of any drug-eluting stent (less than 1mm) enabling exceptional deliverability. Once delivered, the Resolute Onyx 2mm drug-eluting is engineered to expand from 2mm to the maximum labelled expansion diameter of 3.25mm.

The Resolute Onyx drug-eluting platform is the first-and-only stent to feature Core Wire Technology, an evolution of Continuous Sinusoid Technology (CST). CST is a unique Medtronic method of stent manufacturing, which involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent. Core Wire Technology enables thinner struts while maintaining structural strength and visibility.

Matthew J Price (Scripps Clinic in La Jolla, USA), national principal investigator of the RESOLUTE ONYX 2.0 mm clinical study that supported the recent FDA approval, comments: “Patients with lesions in small vessels or complex vasculatures can present unique challenges for physicians during PCI procedures. The Resolute Onyx 2mm drug-eluting stent is an extremely deliverable stent that, when needed, can be post-dilated to 3.2 mm to treat lesions in difficult-to-reach areas of the heart.”

The Resolute Onyx 2mm drug-eluting stent is supported by the RESOLUTE ONYX 2.0 mm Clinical Study, which was presented at the 2017 EuroPCR annual meeting and simultaneously published in the Journal of the American College of Cardiology (JACC): Cardiovascular Intervention. In the study, the Resolute Onyx DES met its pre-specified performance goal with low target lesion failure (5%), low target lesion revascularisation (2%), no episodes of stent thrombosis and no cardiac death at 12 months.

Dave Moeller, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic, comments: “Furthering our core objective of developing technologies that address unmet patient needs, the introduction of the Resolute Onyx 2mm drug-eluting stent allows physicians to expand treatment options for patients with smaller vessels. The Resolute Onyx drug-eluting stent is an incredibly deliverable product that incorporates various design enhancements enabling physicians to optimise treatment for a wide range of patients.”

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