Alert Indications, Safety, and Warnings

Resolute Onyx Coronary Drug-Eluting Stent

Resolute Onyx™ drug-eluting stent (DES) is a stent and balloon catheter delivery system designed to be placed inside a diseased coronary artery to keep the artery open so that blood can access the heart.

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Resolute Onyx stent product image on white background
Alert Indications, Safety, and Warnings

Overview

See what makes Resolute Onyx DES different:

High Bleeding Risk Indication

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.1

Designed Differently to Promote Fast Healing

Single-wire Design — increasing conformability and apposition2

BioLinx™ Polymer — offering superior thromboresistance3

Animation of a gold-colored plus symbol that fades in and out

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

Stent Flexibility and Conformability

The Only DES Designed from a Single Wire† 

Resolute Onyx DES is composed of a single-wire strand formed into a continuous sinusoidal waveform, providing a fluid range of motion with greater flexibility and conformability when compared to laser-cut stents.2

Resolute Onyx DES continuous sinusoid single-wire design on white background

Single-wire design

Representation of a laser-cut design used by competitive coronary stents

Laser-cut design

Single-wire Design Benefits

Single-wire design increases deliverability, flexibility, conformability, wall-apposition, and may reduce arterial injury and thrombus formation.2-4

Sinusoid formed wire detail on the Resolute Onyx DES

Sinusoid-formed wire

Close-up depiction of Resolute Onyx helical wrap

Helical wrap

Resolute Onyx laser-fused product

Laser-fused

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Enhanced Visibility

The Only DES With a Platinum-Iridium Core

The platinum-iridium core within Resolute Onyx DES increases radiopacity for accurate stent placement.

Average Visibility Comparison4

Higher Is Better

Graph of independent study results showing Resolute Onyx average visibility is better than competitive stents

 

 

Close-up image of the Resolute Onyx cobalt alloy shell and platinum-iridum core

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Easier Side Branch Access

The Only DES with Truly Rounded Struts

Resolute Onyx DES is designed with rounded struts that may create a smooth passage for side branch access.4

Strut Shape

Round Strut Cross-section
 
 
  1. Resolute Onyx DES
Illustration of Resolute Onyx DES rounded struts

Square Strut Cross-section

  1. Synergy DES
  2. Xience Sierra DES
Illustration of square struts used by competitive coronary stents

Cell Shape

Regular Cell Shape
Resolute Onyx DES

Resolute Onyx DES cell shape

Irregular Cell Shape
Xience Sierra DES

Xience Sierra DES irregular cell shape

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Broad Size Matrix

The Only DES Offering 2.00–5.00 mm Diameters 

The broad Resolute Onyx DES size matrix optimizes stent deployment, now with greater expansion capabilities.

Table image showing all Resolute Onyx DES sizes from 2.00 mm–5.00 mm with latest MSID specifications

Designed Specifically for Large Vessels

4.50 and 5.00 mm sizes now able to expand up to 6.00 mm‡4

Graphic demonstrating Resolute Onyx DES extra-large vessel sizes, which can now expand up to 6.00 mm

Designed Specifically for Small Vessels

2.00 mm size now able to expand up to 3.50 mm‡4

Graphic demonstrating Resolute Onyx 2.00 mm stent, which can now expand up to 3.50 mm

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Exclusive Polymer and Zotarolimus Drug Combination

Proven Components for Optimal Healing

Watch a short video to learn more about the BioLinx polymer.

The Resolute Onyx DES zotarolimus drug effectively inhibits neointimal growth while the exclusive, highly biocompatible BioLinx polymer contributes to minimal inflammation, low thrombotic risk,5 as well as rapid, complete, and functional endothelial healing.§4

Fast Healing Confirmed

The one-month optical coherence tomography (OCT) study investigated early vessel healing in patients with complex coronary artery disease treated with Resolute Onyx DES.

92.3% Stent Coverage at 1 Month6

Graph showing Resolute Onyx DES covered stent surface had 92.3% stent coverage at one month versus 88.2% for covered struts

Strut Coverage

Resolute Onyx DES strut coverage

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Additional Resources

pdf Resolute Onyx HBR Indication Brochure (.pdf)

Download this brochure to learn more about the Onyx ONE Month DAPT clinical program, including results from the Onyx ONE Global Study and Onyx ONE Clear Study.

468KB

View Brochure
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pdf Resolute Onyx DES Product Brochure (.pdf)

Resolute Onyx DES is different by design. Download this brochure to see what sets it apart.

2.4MB

See Brochure
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pdf Resolute Onyx DES Technical Specifications (.pdf)

Download this single-page document summarizing the technical specifications of Resolute Onyx DES.

153KB

Download Spec Sheet
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Educational Resources on Medtronic Academy

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

Log in to Medtronic Academy

Complex PCI

Resolute Onyx DES offers flexibility, conformability, deliverability, and enhanced visibility for complex percutaneous coronary intervention (PCI).

Learn More about Complex PCI

Innovation, Evidence, and Education

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

View the Latest from Medtronic
*

Third-party brands are trademarks of their respective owners.

†

Including Resolute Integrity™ DES, part of the Medtronic DES portfolio.

‡

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

§

In porcine models.

References

1

Resolute Onyx DES, instructions for use.

2

Shown in independent assessment. Data on file at Medtronic.

3

Jinnouchi H, Sato Y, Cheng Q, et al. Thromboresistance and endothelial healing in polymer-coated versus polymer-free drug-eluting stents: Implications for short-term dual anti-platelet therapy. Int J Cardiol. March 15, 2021;327:52-57.

4

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

5

Silber S, Kirtane AJ, Belardi JA, et al. Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation. Eur Heart J. August 1, 2014;35(29):1949-1956.

6

Roleder T, Kedhi E, Berta B, et al. Short-term stent coverage of second-generation zotarolimus-eluting durable polymer stents: Onyx one-month optical coherence tomography study. Adv Interv Cardiol. 2019;15(2):143-150.