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 with 1-month DAPT Labeling

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

Close up of Resolute Onyx DES with animated spotlight

Designed Differently to Promote Fast Healing

Single-wire Design — increasing conformability and apposition2

BioLinx Polymer — offering superior thromboresistance3

#

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.4

Image of a continuous sinusoid single wire

Single-wire design

Image of laser cut design on white background

vs. 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

Image of Resolute Onyx sinusoid-formed wire

Sinusoid formed wire

Image of Resolute Onyx helical wrap

Helical wrap

Image of 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 showing average visibility comparison

 

 

Image call out of cobalt alloy shell and platinum iridum core

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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 showing round strut shape

Square Strut Cross-Section

  1. Synergy™* DES
  2. Xience Sierra™* DES
Illustration showing square strut shape

cell shape

Regular Cell Shape
Resolute Onyx DES

Image showing regular cell shape

Irregular Cell Shape
Xience Sierra™* DES

Image showing irregular cell shape

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BROADEST SIZE MATRIX

The only DES offering 2.0-5.0 mm diameters 

The Resolute Onyx DES broad size matrix optimizes stent deployment and expansion.

Table showing drug-eluting stent size ranges

Designed Specifically for Large Vessels

Image of maximum expansion left main stent

5.75 mm maximum expansion for 4.50 and 5.00 mm sizes4‡

Designed Specifically for Small Vessels

Graphic showing small maximum vessel expansions 2.0mm - 3.25 mm

3.25 mm maximum expansion for 2.0 mm sizes4‡

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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 risk5, as well as rapid, complete, and functional endothelial healing.4§

Fast Healing Confirmed

The 1-month 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 comparing covered struts vs.covered stent surface

Strut Coverage

Graphic of healing strut

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DOWNLOAD 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

Resolute Onyx HBR Indication Brochure

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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
*

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.

†

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 on the label 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

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

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.