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Answering the most relevant
clinical questions in complex patients
Patients and lesions can be complex, increasing the burden on your practice. Medtronic is committed to advancing clinical data to provide the insights you may need for your patients. Even better, clinical data evaluating Resolute Onyx™ DES also applies to Onyx Frontier™ DES.
Resolute Onyx™ DES was shown to be safe and effective in complex, real-world, high bleeding risk (HBR) patients.1,2
Onyx ONE Global Trial results
Published by The New England Journal of Medicine
Onyx ONE Clear Analysis
Published by Circulation: Cardiovascular Interventions
Onyx ONE Global Trial
Onyx ONE Clear Analysis
The Medtronic DES extra-large platform was specifically designed to treat larger coronary vessel sizes, and their ability to expand to 6.0 mm makes them ideal for clinical research.
Largest prospective study on left main (LM) PCI with a DES that has a dedicated extra-large stent platform (N = 450)
Low 5.1% TLF, 2.0% TLR, and 1.1% ST at one year5
Resolute Onyx™ DES was safe and effective in complex, left main PCI with 99% device success.5
First randomised trial based on European Bifurcation Club (EBC) consensus, comparing a provisional to a planned, dual-stent strategy, LM bifurcation PCI (N = 467)
Resolute Onyx™ DES demonstrated excellent outcomes at one year6
The Medtronic DES small-vessel platform starts at 2.00 mm, and its exceptional deliverability helps reach distal, highly occluded, small vessels.7
Single-arm prospective registry studying Resolute Onyx™ DES in small-vessel PCI (N = 302)
Complex patient population
0% stent thrombosis and low rate of CD-TLR at one year8
Resolute Onyx™ DES was safe and effective in complex, small coronary vessels.8
Medtronic DES have shown outstanding safety and efficacy in a complex, real-world patient population.10
Prospective, single-blinded trial with 1:1 randomisation to look at Resolute Onyx™ DES durable polymer coating versus Orsiro DES bioresorbable coating — stratifying for gender and diabetes (N = 2,470)
Definite or probable stent thrombosis
Long-term safety shown at three-year follow-up with Resolute Onyx™ DES.9–11
™Third-party brands are trademarks of their respective owners.
Resolute Onyx™ DES received CE mark approval for 1-month DAPT in HBR patients in 2020.
Windecker S, Latib A, Kedhi E, et al. Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk. N Engl J Med. March 26, 2020;382(13):1208-1218.
Windecker S, et al. Final Two-Year Results from the Randomized Onyx ONE Trial in High Bleeding Risk Patients Treated with 1-month DAPT. Presented at ACC 2021.
Kandzari DE, Kirtane AJ, Windecker S, et al. One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients. Circ Cardiovasc Interv. November 2020;13(11):e009565.
Resolute Onyx DES IFU M981345A001 Rev. AA..
Tarantini G, et al. The ROLEX Registry (Revascularization Of LEft Main With Resolute onyX). Presented at PCR 2022. Investigator-initiated study funded by Medtronic.
Hildick-Smith D, Egred M, Banning A, et al. The European bifurcation club Left Main Coronary Stent study: a randomized comparison of stepwise provisional vs. systematic dual stenting strategies (EBC MAIN). Eur Heart J. October 1, 2021;42(37):3829-3839.
Based on bench test data on file at Medtronic (method 10036340DOC). May not be indicative of clinical performance. Minimum of N=10 of each DES tested: Resolute Onyx DES, Orsiro DES, XIENCE Alpine™* DES, SYNERGY™* DES, Ultimaster™* DES.
Cuellas C, et al. Use of a Zotarolimus-eluting stent for small vessel disease (DISCO 9 Study). Presented at PCR 2021.
Buiten RA, Ploumen EH, Zocca P, et al. Thin Composite-Wire-Strut ZES Versus Ultrathin-Strut SES in BIONYX at 2 Years. JACC Cardiovasc Interv. May 2020;13(9):1100-1109.
Von Birgelen C, Zocca P, Buiten RA, et al. Thin composite wire strut, durable polymer-coated (Resolute Onyx) versus ultrathin cobalt-chromium strut, bioresorbable polymer-coated (Orsiro) drug-eluting stents in allcomers with coronary artery disease (BIONYX): an international, single-blind, randomised non-inferiority trial. Lancet. October 6, 2018;392(10154):1235-1245.
Ploumen E, et al. Data presented at ACC 2021. Investigator-initiated study funded by Medtronic, BIOTRONIK.
See the device manual for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu.
For applicable products, consult instructions for use on www.medtronic.com/manuals. Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.
Important Reminder: this information is intended only for users in markets where Medtronic products and therapies are approved or available for use as indicated within the respective product manuals. Content on specific Medtronic products and therapies is not intended for users in markets that do not have authorization for use.