February 26, 2018 – Designed specifically for small vessels, Medtronic plc announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of the Resolute Onyx 2 mm Drug-Eluting Stent (DES), what it calls the smallest sized DES on the market. The new stent is intended to help interventional cardiologists treat patients with coronary artery disease (CAD) who have small vessels often untreatable with larger stent technologies during percutaneous coronary intervention (PCI). It is estimated that approximately 65 percent of smaller vessels (≤ 2.25 mm) are in critical locations of the heart, making them significant lesions to treat.[i]
“Patients with lesions in small vessels or complex vasculatures can present unique challenges for physicians during PCI procedures,” said Matthew J. Price, M.D., interventional cardiologist at Scripps Clinic in La Jolla, Calif., and national principal investigator of the RESOLUTE ONYX 2.0 mm Clinical Study, which supported the recent FDA approval. “The Resolute Onyx 2 mm DES is an extremely deliverable stent that, when needed, can be post-dilated to 3.25 mm to treat lesions in difficult-to-reach areas of the heart.”
The first-and-only 2 mm DES size available in the U.S., the newly approved stent joins the Resolute Onyx 4.5- and 5-mm DES to provide physicians with the broadest DES size matrix available, according to Medtronic, expanding treatment options for patients with the smallest coronary vessels to the largest, from the simplest of anatomies to the complex. In addition, the stent is engineered with the lowest crossing profile of any DES (less than 1 mm), enabling exceptional deliverability, according to the company. Once delivered, the Resolute Onyx 2.0 mm DES is engineered to expand from 2 mm to the maximum labeled expansion diameter of 3.25 mm.
The Resolute Onyx DES platform features Core Wire Technology, an evolution of Continuous Sinusoid Technology (CST). CST is Medtronic’s 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.
The new device 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 percent), low target lesion revascularization (2 percent), no episodes of stent thrombosis and no cardiac death at 12 months.
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 the CE Mark.
For more information: www.medtronic.com
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