Complex PCI

Resolute Onyx Drug-Eluting Stent

Alert Indications, Safety, and Warnings

Overview

Resolute Onyx™ DES offers flexibility, conformability, deliverability, and enhanced visibility1 for complex percutaneous coronary intervention (PCI), including:   


High bleeding risk patients
Chronic total occlusion
Small vessels (2.0 mm)
Extra-large vessels (4.5­–5.0 mm)
Diabetic patients

Resolute Onyx Stent product image on white background

HIGH BLEEDING RISK PATIENTS

Indicated for HBR Patients with 1-month DAPT Labeling

Resolute Onyx is the only DES proven safe and effective in high bleeding risk (HBR) patients with 1-month DAPT labeling, based on results from the Onyx ONE Clear Analysis.2

Close up of Resolute Onyx DES with animated spotlight

Designed Differently to Promote Fast Healing

Single-wire Design — increasing conformability and apposition3

BioLinx Polymer — offering superior thromboresistance4

#

Backed by 1-month DAPT Evidence

The Onyx ONE Month DAPT Program

  • Onyx ONE Global Study — results published in The New England Journal of Medicine
  • Onyx ONE Clear Study

Review the Data

Chronic Total Occlusion

Resolute Onyx DES offers exceptional deliverability and enhanced visibility1 for complex chronic total occlusion (CTO) cases.

CTO PERFORMANCE BACKED BY EVIDENCE2†

92.3% Procedural Success

96.2% Technical Success

1.1% TLR  at one year

0.6% Stent Thrombosis at one year

SEE MORE ABOUT CTO

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Small Vessels

When it comes to treating small vessels, Resolute Onyx DES offers the lowest crossing profile for superior deliverability1‡ and is engineered to expand from 2.0 mm to 3.25 mm.1§

The Most Deliverable Stent1‡

Lower Is Better
Average Force (gF) 

Graph showing Resolute Onyx DES deliverability compared to others

ENGINEERED TO EXPAND

Graphic showing small maximum vessel expansions 2.0mm - 3.25 mm

Our smallest DES expands from 2.0–3.25 mm
and features low foreshortening when
expanded to 3.25 mm.1§

3.25 mm
Post-dilatation limit for 2.0 mm sizes.

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Extra-Large Vessels

As the first DES with 4.5 and 5.0 mm sizes, Resolute Onyx DES expands treatment options for patients with extra-large vessels. It sustains structural strength and coating integrity when overexpanded and its 5 Fr compatibility is designed with the transradial approach in mind.  

Even Scaffolding at OverExpansion1§

Resolute Onyx DES
5.0 mm x 18 mm DES

Maximum distance between stent struts

1.62 mm maximum distance between stent struts

Synergy DES
4.0 mm x 20 mm DES

Image of Synergy DES scaffolding at over-expansion distance

1.87 mm maximum distance between stent struts

Deployed to 5.75 mm (maximum labeled overexpansion)1§

SUSTAINED RADIAL STRENGTH1

Higher Is Better

Graph showing Resolute Onyx DES maintains higher compression resistance compared to others

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Diabetic Patients

In recent Medtronic studies, diabetes patients make up over 35% of the coronary stents implanted.5-6

The Medtronic DES portfolio was the first indicated for CAD treatment in patients with diabetes.1

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Educational Resources on Medtronic Academy

Log in to Medtronic Academy to browse a variety of Coronary education, training, and resources.

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Resolute

Onyx DES

Resolute Onyx DES is designed to be placed inside a diseased coronary artery to keep the artery open so that blood can access the heart.

View Resolute Onyx DES

Innovation, Evidence, and education

View our latest product and therapy innovations, clinical evidence, and educational offerings for the interventional cardiology space.

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*

Medtronic and Medtronic logo are trademarks of Medtronic.  Third-party trademarks ("™*") belong to their respective owners.  All other brands are trademarks of a Medtronic entity.

†

Endpoints presented from the PERSPECTIVE Study (NCT02884206) were not powered.

‡

Testing performed on smallest diameters available for Abbott Xience Alpine™*, Biotronik Orsiro™*, Boston Scientific Promus Premier™*, Boston Scientific Synergy™*, Medtronic Resolute Integrity™, and Medtronic Resolute Onyx coronary stents.

§

The Resolute Onyx stents should not be expanded to a diameter beyond the maximum labeled diameter listed on the label per the IFU. Post-dilatation required for overexpansion.

1

Based on bench test data on file at Medtronic. May not be indicative of clinical performance.

2

Resolute Onyx DES, Instructions for Use.

3

Shown in independent assessment. Data on file at Medtronic.

4

Finn, et al. Assessment of acute thrombogenicity and albumin bindings in the Resolute Onyx Zotarolimus-eluting Coronary Stent System. Data presented at PCR 2019.

5

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.

6

Kirtane A, et al. One Month Dual Antiplatelet Therapy in High Bleeding Risk Patients: Primary Results of Onyx ONE Clear. Presented online at ACC 2020.