Medtronic's Resolute Onyx 2.0-mm DES Approved and Launched in the United States

February 26, 2018—Medtronic announced US Food and Drug Administration (FDA) approval and the United States launch of the company's Resolute Onyx 2.0-mm drug-eluting stent (DES), which is specifically designed to treat small vessels.

According to Medtronic, the Resolute Onyx 2.0-mm DES is engineered with a ≤ 1-mm crossing profile. Once delivered, it expands from 2.0 mm to 3.25 mm, the maximum labeled expansion diameter. The new device joins the Resolute Onyx 4.5- and 5.0-mm DES. The Resolute Onyx DES is available for use in all sizes in the United States, as well as in Europe and other countries that recognize CE Mark approval.

The Resolute Onyx 2.0-mm DES is intended to treat patients with coronary artery disease who have small vessels, which are often untreatable with larger stent technologies during percutaneous coronary intervention (PCI).

The FDA approval was supported by findings from the RESOLUTE ONYX 2.0 mm clinical study, which was led by National Principal Investigator Matthew J. Price, MD.

In Medtronic's announcement, Matthew J. Price, MD, commented, "Patients with lesions in small vessels or complex vasculatures can present unique challenges for physicians during PCI procedures. The Resolute Onyx 2.0-mm DES is an extremely deliverable stent that, when needed, can be postdilated to 3.25 mm to treat lesions in difficult-to-reach areas of the heart."

In May 2017, Dr. Price presented the findings from the RESOLUTE ONYX 2.0 mm clinical study at the 2017 EuroPCR conference in Paris, France. Dr. Price et al simultaneously published the data in Journal of the American College of Cardiology: Cardiovascular Interventions.

In the study, the Resolute Onyx DES met its prespecified performance goal with low target lesion failure (5%), low target lesion revascularization (2%), no episodes of stent thrombosis, and no cardiac death at 12 months, noted Medtronic.