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

Nuance Communications Inc. introduced Nuance Cardiovascular CAPD, a new computer-assisted physician documentation (CAPD) solution designed to help cardiologists improve the quality of complex documentation and the accuracy of reimbursement for cardiac catheterization procedures. The Nuance Cardiovascular CAPD solution is available through a partnership with ZHealth for this solution, which is based on patented algorithms built with ZHealth’s interventional documentation and coding expertise.
News | Cath Lab | January 31, 2020
January 29, 2020 – Nuance Communications Inc.
Videos | Cath Lab | January 09, 2020
Haval Chweich, M.D., medical director of the cardiac critical care unit (CCU) at Tufts Medical Center, and assistant...
People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.  In early December 2019, leaders of the European Association for Cardiothoracic Surgery (EACTS) withdrew their support for European practice guidelines that endorse the use of coronary stents in many patients with left main coronary artery disease.

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.

News | Cath Lab | January 02, 2020 | Dave Fornell, Editor
January 2, 2020 — In early December 2019, leaders of the European As...
News | Cath Lab | December 18, 2019
December 18, 2019 — Cook Medical initiated a recall of its CrossCath Support Catheters in November, which the U.S.
Gallery | Cath Lab | October 31, 2019 | Dave Fornell, Editor
This is a photo essay of the interventional cardiology and structural heart technologies on the expo floor and discus
The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

Technology | Cath Lab | October 28, 2019
Office based labs (OBLs) and ambulatory surgery centers (ASCs) require a fresh perspective from imaging vendors.
Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

News | Cath Lab | October 28, 2019
October 28, 2019 — Leaders within University Hospitals and the Harrington Heart and Vascular Institute had a vision t