Alert Indications, Safety, and Warnings

Onyx Frontier™ DES for coronary artery disease

Onyx Frontier™ is a drug-eluting stent (DES) that’s engineered to deliver, different by design, and optimised for complex percutaneous coronary interventions (PCI).

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Onyx Frontier stent on a transparent background
Alert Indications, Safety, and Warnings

Overview

Onyx FrontierTM DES introduces an enhanced delivery system for its 2.0–4.0 mm sizes† and is designed to take the acute performance of Resolute Onyx™ DES even further.

Enhanced delivery system

Onyx Frontier™ DES is engineered to deliver,† featuring:

  1. A dual-flex balloon
  2. A lower crossing profile1
  3. Increased catheter flexibility2
Onyx Frontier stent with callouts to highlight the deliverability enhancements

See the latest technology in action.

Deliverability comparison — 3.0 mm DES3

(Lower is better)

Graph comparing Onyx Frontier DES deliverability with competitive stents

2-D track maximum force (gf scaled)

Onyx Frontier™ is the most deliverable DES yet.3

  • 16% more deliverable than Resolute Onyx™ DES
  • 24% more deliverable than Orsiro™ Mission DES
  • 26% more deliverable than Ultimaster™ Tansei DES
  • 46% more deliverable than SYNERGY™ XD DES
  • 62% more deliverable than XIENCE Skypoint™ DES

Stent crossing profile comparison — 3.0 mm DES1

(Lower is better)

Graph comparing Onyx Frontier DES crossing profile with competitive stents

Average stent crossing profile (in)

Onyx Frontier™ is the only 3.0 mm DES with a crossing profile less than 1 mm.1

† Stent delivery system updates were implemented on the 2.0–4.0 mm Onyx Frontier™ DES diameters.

Product features

Onyx Frontier™ DES is different by design, featuring:

Watch short animation on product features:

Single-wire design

In comparison to laser-cut drug-eluting stents, only Medtronic DES are made from a single wire to enable a fluid range of motion and the conformability needed for superior strut apposition.4

Sinusoid-formed wire detail on Medtronic DES

Sinusoid-formed wire

Close-up depiction of Medtronic DES helical wrap

Helical wrap

Curved view of Medtronic DES highlights how it is laser-fused

Laser-fused design

Platinum-iridium core

The platinum-iridium core within Onyx Frontier™ DES is more visible than competitive DES, while enabling greater radial strength with thin struts.‡5

Interior of Onyx Frontier DES, which is a platinum-iridium core, and the exterior, which is cobalt alloy shell
  1. Cobalt alloy shell
  2. Platinum-iridium core

Visibility comparison — 3.0 mm DES5

(Higher is better)

Graph comparing Onyx Frontier DES visibility with competitive stents

Average X-ray visibility index (%)

Zotarolimus drug and Biolinx™ polymer

The zotarolimus drug inhibits neointimal growth6 while the BioLinx biocompatible polymer — the only polymer specifically designed for a DES — promotes faster healing.7

Illustration of the BioLinx polymer — part of Onyx Frontier DES

Broad diameter range

Only Medtronic offers DES in 2.0 to 5.0 mm sizes, with overexpansion capabilities up to 6.0 mm,§ to treat the broadest range of coronary vessel diameters.

Platform

Stent
diameter (mm)

Stent length (mm)

MSID§ (mm)
(post-dilatation limit)

Small
vessels

2.00

8

12

15

18

22

26

30

 — 

 —

3.50

2.25

8 

12 

15 

18 

22

26

30

34

38 

3.50 

2.50

8

12 

15 

18 

22

26

30 

34 

38 

3.50 

Medium
vessels

2.75

8 

12 

15 

18 

22

26

30 

34 

38 

4.00 

3.00

8 

12 

15 

18 

22 

26

30 

34 

38 

4.00 

Large
vessels

3.50

8

12 

15 

18 

22 

26

30 

34 

38 

5.00 

4.00

8 

12 

15 

18 

22

26

30 

34 

38 

5.00 

Extra-large
vessels

4.50

 —

12 

15 

18 

22 

26

30 

 —

 —

6.00 

5.00

 —

12 

15 

18 

22 

26

30 

 —

 —

6.00 

 

Complex PCI

Optimised for complex PCI

An exclusive set of design features and clinical data help ensure you have a reliable DES, even for your most challenging cases:

Left main and other extra-large vessel PCI
(4.50–⁠5.00 mm sizes)

  • Specifically designed with additional crowns and thicker struts to provide the radial strength needed for extra-large vessels8
  • Maintain a low profile,8 allowing for 5 F compatibility
  • 4.50–5.00 mm expand up to 6.00 mm§ while maintaining structural integrity8
See left main data
Onyx Frontier DES expanded to 6.0 mm next to medical illustration of Onyx in the body under fluoro

Bifurcation PCI

  • Other DES feature irregular cell shapes which may obstruct wire or catheter advancement through the cell’s opening.8
  • Round struts create a smooth passage when accessing the side branch while lowering the propensity to catch.8
Illustration of Onyx Frontier DES inside the body with a catheter running through it and out of it

Rounded struts

Illustration of Medtronic DES' rounded struts

1. Onyx Frontier™ DES‡

Square struts

Illustration of square struts used by competitive coronary stents

1. SYNERGY™* DES
2. XIENCE™* DES

Extra-small vessel PCI
(2.00–2.50 mm sizes)

  • 2.00 mm offers the lowest crossing profile of any DES8
  • Demonstrated 2% target lesion revascularisation and 0% stent thrombosis at one year in a complex, small-vessel population9
  • 2.00–2.50 mm expand up to 3.50 mm§ with minimal foreshortening for tapered and extra-small vessels8
Onyx Frontier DES 3.5 mm maximum stent inner diameter next to medical illustration of Onyx in the body under fluoro

HBR patients who may require 1-month dual antiplatelet therapy (DAPT)

  • Up to 40% of patients are at high bleeding risk (HBR) while 20% may need to interrupt or discontinue DAPT earlier than prescribed.10,11
  • Onyx Frontier™ DES is conformable, providing superior strut apposition4 while the BioLinx™ biocompatible polymer provides superior thromboresistance.12 When combined, fast healing occurred,7 providing the option to shorten DAPT duration to 1-month in HBR patients.
  • Based on the results from the Onyx ONE Global Trial, Onyx Frontier™ DES is indicated for 1-month DAPT in HBR patients, including those unable to tolerate long-term DAPT.13
Download Onyx ONE data
Illustration of the Onyx Frontier DES shown inside the artery

MRI safety

Nonclinical testing has demonstrated that the Onyx Frontier™ stent is MR Conditional for single and overlapping lengths up to 120 mm. A person with the Onyx Frontier™ DES implant may be safely scanned under the conditions found in the Onyx Frontier™ DES instructions for use. Failure to follow these conditions may result in injury.

Additional resources

Medtronic DES clinical evidence

See an overview of our DES clinical evidence to date.

Learn more

Bifurcation education

View five techniques that highlight Resolute Onyx™ DES through endoscopic imaging captured inside an isolated and reanimated beating porcine heart. 

Visit and bookmark

Request more information

Contact us
*

™Third-party brands are trademarks of their respective owners.

†

Stent delivery system updates were implemented on the 2.0–4.0 mm Onyx Frontier™ DES diameters.

‡

Onyx Frontier™ DES has the same stent platform, with platinum-iridium core, as Resolute Onyx™ DES. 

§

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

||

Indications may vary by country. Refer to local instructions for use.

References

1

Based on bench test data on file at Medtronic. [D00339634 - Test Report for DES Competitive Comparison with Frontier test methods, Rev C, 05-May-2022] May not be indicative of clinical performance. N = 5 DES of each tested: Onyx Frontier DES, Orsiro Mission DES, Resolute Onyx DES, XIENCE Skypoint DES, SYNERGY DES, Ultimaster Tansei DES.

2

Based on bench test data on file at Medtronic. [44RD21031-040047 Onyx Frontier Vs Resolute Onyx Balloon Extrusion, Version 1.0, 17-Feb-2022] May not be indicative of clinical performance.

3

Based on bench test data on file at Medtronic. [D00339634 - Test Report for DES Competitive Comparison with Frontier test methods, Rev C, 05-May-2022] May not be indicative of clinical performance. N = 7 DES of each tested: Onyx Frontier DES, Resolute Onyx DES, Orsiro®* Mission DES, XIENCE Sierra™* DES, XIENCE Skypoint™* DES, SYNERGY™* DES, SYNERGY™* XD DES, Ultimaster™* Tansei™* DES.

4

Third-party modeling and analysis. [Mortier MDT-ON14-report-curved-v10-20150220_ Onyx_Synergy] Data may not be indicative of clinical performance. Evaluated the following stent platforms: Resolute Onyx DES, Multi-Link 8™* BMS, SYNERGY™* DES, XIENCE Alpine™* DES, and Multi-Link 8 platform.

5

Based on bench test data on file at Medtronic. [University of Budapest Visibility Testing, V0.1, 28-Sep-2021; 10166182DOC Competitive Analysis Test Report, Rev AC, 08-Jun-2021] May not be indicative of clinical performance. Stents tested include Resolute Onyx DES, SYNERGY DES, XIENCE Sierra™* DES, and Orsiro DES.

6

Yeh RW, Silber S, Chen L, et al. 5-Year Safety and Efficacy of Resolute Zotarolimus-Eluting Stent: The RESOLUTE Global Clinical Trial Program. JACC Cardiovasc Interv. February 2017;10(3):247-254.

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.

8

Bench test data on file at Medtronic. [D00333762 Synergy Megatron (3.5, 5.0mm diameter) Competitive Testing Study, Rev A, 08-Feb-2021] May not be indicative of clinical performance.

9

Cuellas C, et al. Use of a Zotarolimus-eluting stent for small vessel disease (DISCO 9 Study). Presented at PCR 2021.

10

Windecker S. Stent Selection for 1-3 Month DAPT: Current Evidence Ongoing Studies. Presented at TCT 2018; San Diego, CA.

11

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.

12

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.

13

Windecker S, et al. N Engl J Med. 2020;382:1208-1218.

Brief statement

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.

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