Technology | Stents Drug Eluting | February 26, 2018

Medtronic Launches 2 mm Onyx DES

New version of Onyx DES tackles clinical challenge of treating coronary artery disease in previously untreatable patients with small vessels

Medtronic Launches 2 mm Onyx DES

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

Related Onyx DES Content

FDA Approves Medtronic Resolute Onyx Drug-eluting Stent

Resolute Onyx 2.0 mm Stent Performs Well in Small Vessels

VIDEO: Resolute Onyx Drug-Eluting Stent Procedural Animation

 

References

[i] Schunkert et al. JACC July 1999


Related Content

News | Cath Lab

May 31, 2022 — Innovative Health, LLC, a specialty cardiology reprocessor, announced that the company has received ...

Home May 31, 2022
Home
News | Cath Lab

May 26, 2022 — The U.S. Food and Drug Administration (FDA) has recalled the Dragonfly OpStar Imaging Catheter, and has ...

Home May 26, 2022
Home
News | Cath Lab
April 25, 2022 – NewYork-Presbyterian Hudson Valley Hospital celebrated the launch of its interventional cardiology ...
Home April 25, 2022
Home
News | Cath Lab
April 18, 2022 – Royal Philips and Oulu University Hospital (Finland) have announced a strategic 10-year partnership ...
Home April 18, 2022
Home
News | Cath Lab
February 16, 2022 – Fremont Bank Foundation recently donated $750,000 to its community partner, St. Rose Hospital ...
Home February 16, 2022
Home
News | Cath Lab
February 14, 2022 — A collaborative effort between The Valley Heart and Vascular Institute’s cardiology team ...
Home February 14, 2022
Home
Sponsored Content | Videos | Cath Lab

Advancements in analytics and data visualizations are helping to streamline operations and improve productivity at cath ...

Home January 13, 2022
Home
News | Cath Lab

January 4, 2022 — The U.S. Food and Drug Administration (FDA) has authorized marketing of the first laser-based device ...

Home January 04, 2022
Home
News | Cath Lab

December 14, 2021 — RSIP Vision, a medical imaging company applying advanced artificial intelligence (AI) and computer ...

Home December 14, 2021
Home
Feature | Cath Lab

November 15, 2021 — RealView Imaging Ltd. recently received FDA 510(k) clearance for its Holoscope-i holographic system ...

Home November 15, 2021
Home
Subscribe Now