Onyx TruStar™ DES Designed to lead the way
Onyx TruStar™ DES introduces an enhanced delivery system§ designed to take the acute performance of Resolute Onyx™ DES even further.
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Overview
Onyx TruStarTM DES...
more deliverable than Resolute Onyx™ DES1
lower crossing profile than Resolute Onyx™ DES7
more flexible than Resolute Onyx™ DES2
Onyx TruStar™ DES builds off the legacy of Resolute Onyx DES, featuring the same stent design differentiators that provide the conformability,3 visibility,4 fast healing,5 and size matrix you’ve come to rely on.
Increased conformability: 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.3
Increased visibility and radial strength: platinum-iridium core
The platinum-iridium core within Onyx TruStar™ DES is more visible4 than competitive DES, while still enabling greater radial strength4 with thin struts.‡
Promotes faster healing5: BioLinx™ biocompatible polymer
The zotarolimus drug inhibits neointimal growth,6 while the BioLinx biocompatible polymer — the only polymer specifically designed for a DES — promotes fast healing and enables 1-month DAPT in high bleeding risk patients.
Broad diameter range
Only Medtronic offers DES in 2.0 mm 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 | MSID#(mm) |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Small vessels | 2.00 2.25 2.50 |
8 8 8 |
12 12 12 |
15 15 15 |
18 18 18 |
22 22 22 |
26 26 26 |
30 30 30 |
-- 34 34 |
-- 38 38 |
3.50 3.50 3.50 |
| Medium vessels | 2.75 3.00 |
8 8 |
12 12 |
15 15 |
18 18 |
22 22 |
26 26 |
30 30 |
34 34 |
38 38 |
4.00 4.00 |
| Large vessels | 3.50 4.00 |
8 8 |
12 12 |
15 15 |
18 18 |
22 22 |
26 26 |
30 30 |
34 34 |
38 38 |
5.00 5.00 |
| Extra-large vessels | 4.50 5.00 |
- - |
12 12 |
15 15 |
18 18 |
22 22 |
26 26 |
30 30 |
-- -- |
-- -- |
6.00 6.00 |
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 vessels7
- Maintain a low profile,7 allowing for 5 F compatibility
- 4.50–5.00 mm expand up to 6.00 mm# while maintaining structural integrity7
Bifurcation PCI
- Other DES feature irregular cell shapes which may obstruct wire or catheter advancement through the cell’s opening.7
- Round struts create a smooth passage when accessing the side branch while lowering the propensity to catch.7
- Other DES feature irregular cell shapes which may obstruct wire or catheter advancement through the cell’s opening.7
- Round struts create a smooth passage when accessing the side branch while lowering the propensity to catch.7
Rounded struts
Onyx TruStarTM DES‡
Square struts
1. Other DES in the market 1
2. Other DES in the market 2
Extra-small vessel PCI (2.00–2.50 mm sizes)
- 2.00 mm offers the lowest crossing profile of any DES7
- Demonstrated 2% target lesion revascularisation and 0% stent thrombosis at one year in a complex, small-vessel population8
- 2.00–2.50 mm expand up to 3.50 mm# with minimal foreshortening for tapered and extra-small vessels7
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.9,10
- Onyx Frontier™ DES is conformable, providing superior strut apposition12 while the BioLinx™ biocompatible polymer provides superior thromboresistance.11 When combined, fast healing occurred,5 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
§ Stent delivery system updates were implemented on the 2.0–4.0 mm Onyx TruStar DES diameter.
# Stents should not be expanded to a diameter beyond the maximum labeled diameter listed per the IFU. Post-dilation required for overexpansion.
‡ Onyx TruStar DES has the same stent platform, with platinum-iridium core, as Resolute Onyx DES.
References
1
Based on bench test data on file at Medtronic, D00339634, Rev C. May not be indicative of clinical performance. N = 7 DES of each tested: Onyx TruStar DES, Resolute Onyx DES, Orsiro®* DES, XIENCE Sierra™* DES, SYNERGY™* DES.
2
Based on bench test data on file at Medtronic, D00624519, Rev A. Compared to Resolute Onyx DES. May not be indicative of clinical performance
3
Third-party modeling and analysis, Mortier MDT-ON14-report-curved-v10-20150220_Onyx_Synergy.pdf. May not be indicative of clinical performance. Evaluated the following stent platforms: Resolute Onyx DES, SYNERGY™* DES, and XIENCE Alpine™* DES (Multi-Link 8 platform).
4
Based on bench test data on file at Medtronic, CO10276086 University of Budapest Visibility Testing, v1. May not be indicative of clinical performance.
5
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.
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 13, 2017;10(3):247-254.
7
Based on bench test data on file at Medtronic, D00339634, Rev C. May not be indicative of clinical performance. N=5 of each DES tested.
8
Cuellas C, et al. Use of a Zotarolimus-eluting stent for small vessel disease (DISCO 9 Study). Presented at PCR 2021.
9
Windecker S. Stent Selection for 1-3 Month DAPT: Current Evidence Ongoing Studies. Presented at TCT 2018; San Diego, CA.
10
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.
11
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.
12
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.
13
Windecker S, et al. N Engl J Med. 2020;382:1208-1218.
Brief statement
This material is for Healthcare Professionals in countries with applicable health authority product registrations.
Important: Always refer to the Instructions For Use (IFU) packaged with the product/e-IFU for complete instructions, indications, contraindications, warnings, and precautions.
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 manuals.medtronic.com. Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.