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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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:
- A dual-flex balloon
- A lower crossing profile1
- Increased catheter flexibility2
See the latest technology in action.
† 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:
Sinusoid-formed wire
Helical wrap
Laser-fused design
1. Cobalt alloy shell
2. Platinum-iridium core
| Platform |
Stent |
Stent length (mm) |
MSID§ (mm) |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Small |
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 |
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 |
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 |
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
Rounded struts
1. Onyx Frontier™ 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
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 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
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.
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*
™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 cema.medtronic.com.
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.