Alert Indications, Safety, and Warnings

Resolute Onyx DES for Coronary Artery Disease

Resolute Onyx™ is a drug-eluting stent (DES) that's different by design, which makes it optimized for complex PCI. It's safe and effective in real-world, high bleeding risk patients on 1-month DAPT.1

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

Overview

Resolute Onyx DES is different by design, helping to address your DES needs and numerous patient anatomies. It features:

High Bleeding Risk Indication

Indicated for HBR Patients With 1-month DAPT Labeling

Resolute Onyx DES is 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

DAPT duration decisions are best made on an individual basis. Premature discontinuation or interruption of prescribed antiplatelet medication could result in a higher risk of ST, MI, or death.

Designed Differently to Promote Fast Healing

Single-wire Design — increasing conformability and apposition3

BioLinx™ Polymer — offering superior thromboresistance4

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 Trial — 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.3

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.3-5

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 Comparison5

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.5

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

Maximum Expansion Capabilities

Large Vessels

4.50 and 5.00 mm sizes now able to expand up to 6.00 mm‡2

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

Small Vessels

2.00 mm size now able to expand up to 3.50 mm‡2

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

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Exclusive DES Polymer and 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,6 as well as rapid, complete, and functional endothelial healing.§5

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 One Month7

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

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

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.

2

Resolute Onyx DES, instructions for use.

3

Shown in independent assessment. Data on file at Medtronic.

4

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.

5

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

6

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.

7

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.