Precision in every branch

Elevate bifurcation procedures with
Onyx Frontier™ drug-eluting stent (DES)

Bifurcation procedure of Onyx Frontier™ drug-eluting stent (DES) image.

Bifurcation PCI

Bifurcation PCIs are prevalent and complex. 30% of PCIs involve bifurcations,¹ presenting challenges such as adapting to the complex geometry² of the bifurcation, and accessing the side branch.³ Discover how Onyx Frontier™ DES is optimised for bifurcation and left main PCI.

Single-wire image of Onyx Frontier™ DES product.

Excellent conformability

The single-wire design of Onyx Frontier™ DES increases flexibility and conformability for superior strut apposition,⁴ reducing arterial injury and thrombus formation.⁵

Onyx Frontier™ DES open-cell design and round struts product image.

Optimised for side branch access

Onyx Frontier™ DES has an open-cell design and round struts to create a smooth passage for access to the side branch,⁶ which can commonly become occluded during the bifurcation PCI procedure.³

Lowest crossing profile⁷for access to the side branch

Enabled by the thin dual-flex balloon, Onyx Frontier™ DES has the lowest crossing profile^†,7 for smooth delivery to bifurcation lesions and entry to the side branch⁸ where a second stent may be required in 20% of cases treated with the provisional strategy.¹⁶

Left main PCI

Onyx Frontier™ DES is precisely engineered to meet the needs of left main PCI. Left main is the highest risk lesion subset due to the large area of jeopardised myocardium.⁹The left main has the highest elastic content of any coronary artery¹¹ and 75% of left main diameters are 4.5–6.0 mm.¹⁰
Onyx Frontier™ XLV DES is the first stent platform designed for extra-large vessels (XLV)^¶,12 with thicker struts and additional crowns to provide the radial strength needed for extra-large vessels.^‡,13

Bar graph showing that Onyx Frontier™ (XLV) DES radial strength reaches +17% of radial strength than core size.

More radial strength

Onyx Frontier™ (XLV) DES was specifically designed with additional crowns and thicker struts to provide the radial strength needed for the left main^‡,14which has the highest elastic content of any coronary artery.¹¹

Maximum expansion

Onyx Frontier™ (XLV) DES expands to 6.0 mm MSID^§ with optimal deployment while maintaining even scaffolding.

Greater side branch cell diameter

Onyx Frontier™ (XLV) DES can achieve a greater side branch cell diameter¹⁵ to accommodate the large side branches to the LAD and LCx.

Clinical evidence in bifurcation and left main PCI

The most relevant clinical evidence in bifurcation and left main PCI.

The only dedicated (XLV) stent platform with randomised and clinical data supporting its use in left main bifurcations.^¶,16

Studied in ~2,000 bifurcation and left main patients across five impactful trials presented since 2021 (EBC MAIN¹⁶, ROLEX¹², KISS¹⁷, Onyx ONE Clear bifurcation subanalysis¹⁸ and Resolute Onyx Bifurcation study).¹⁹

In EBC MAIN¹⁶ and ROLEX¹², Resolute Onyx™ DES was chosen because of its (XLV) platform, which can expand to 6.0 mm^§ and is the only dedicated (XLV) stent platform with randomized clinical data supporting its use in left main bifurcations.^¶,¹⁶

Take a closer look at the trials.

pdf EBC Main¹⁶ clinical trial (.pdf)

993KB

Download EBC Main

Resolute Onyx and Onyx Frontier EBC Main clinical one-pager, in relation with Bifurcation procedure, file download preview.

pdf ROLEX¹² clinical trial (.pdf)

689KB

Download ROLEX

Resolute Onyx™ and Onyx Frontier™ DES KISS clinical one-pager summary file download preview.

pdf KISS¹⁷ clinical trial (.pdf)

1.3MB

Download KISS

Resolute Onyx™ and Onyx Frontier™ DES KISS clinical one-pager summary, in relation with Bifurcation procedure, file download preview.

Education

Advancing bifurcation education through
meaningful collaborations

Euphora™ Semicompliant balloon dilatation catheter product image inside the vessel during bifurcation procedure.

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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.

‡ Compared to 2.0-4.0 mm sizes.

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

¶ Resolute Onyx XLV DES (4.5 and 5.0 mm sizes) was released in 2016. Onyx Frontier™ DES uses the same stent platform as Resolute Onyx™ DES. Clinical data evaluating Resolute Onyx™ DES apply to Onyx Frontier™ DES. Stent delivery system updates were implemented on the 2.0–4.0 mm Onyx Frontier™ DES diameters.

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

1. Von Birgelen C, et al. Lancet. 2018;392:1235-1245.

2. Onuma et al. EuroIntervention 2019;14:e1568-e1577.

3. Gwon HC. Korean Circ J. 2018;48:481-491.

4. Based on modeling of 3.0 mm stents. Δ Evaluated Onyx Frontier™ DES and Synergy™ DES.

5. Foin N, et al. EuroIntervention. 2017;13:e1096-e1098.

6. Based on bench test data. May not be indicative of clinical performance. N = 10 of each. 3.0 mm platform: Onyx Frontier, Multi-Link 8™* (Abbott), Omega™* (Boston Scientific).

7. Based on bench test data.* n = 5 of each 3.0 mm DES: Onyx Frontier™ DES, Resolute Onyx™ DES, Orsiro Mission™* DES, Xience Skypoint™* DES, Synergy XD™* DES, Ultimaster Nagomi™* DES.

8. Based on bench test data (method D00117002).^¶ n = 7 of each 3.0 mm DES: Onyx Frontier™ DES, Orsiro Mission™* DES, Resolute Onyx™* DES, Xience Skypoint™* DES, Synergy XD™* DES, Ultimaster Nagomi™* DES.

9. Lee PH et al. J Am Coll Cardiol. 2016;68(11):1233-1246.

10. Estimations adapted from an analysis of 125 patients. Shand JA, et al. Catheter Cardiovasc Interv. 2014;84:351-358.

11. Macaya C, et al. Am J Cardiol. 1992;70:105-7.

12. Tarantini G, et al. EuroIntervention. 2023;18(13):e1108-e1119.

13. Based on bench test data. May not be indicative of clinical performance. n = 3 of each 3.0 mm DES: Onyx Frontier™ DES, Orsiro™* DES, Xience™* DES, Synergy™* DES, Ultimaster™* DES.

14. Based on bench test data. May not be indicative of clinical performance. Minimum n = 3 of each Onyx Frontier™ stent platform.

15. Based on bench test data. May not be indicative of clinical performance. n = 3 of each 5.0mm DES.

16. Hildick-Smith D, et al. Eur Heart J. 2021;42:3829-3839.

17. Chevalier B, et al. KISS: provisional stenting in bifurcation lesion: benefit of side branch intervention? Presented at PCR 2024.

18. Kirtane A, et al. Clinical Outcomes in High Bleeding Risk Patients with Bifurcations after PCI with Resolute Onyx™ DES and One Month Dual Antiplatelet Therapy. Presented at TCT 2021

19. Price M, et al. Results from the Resolute Onyx Bifurcation Study. J Am Coll Cardiol. 2021 May, 77:965.

Disclaimer

For distribution only in markets where the Resolute Onyx™ and Onyx Frontier™ coronary stent systems have been approved. Not for distribution in the United States, Canada, Japan, or France.