Drug-eluting stents

Onyx Frontier™ drug-eluting stent (DES)

<p>The Onyx Frontier™ drug-eluting stent (DES) is used for percutaneous transluminal coronary angioplasty (PTCA).</p>

Ordering information
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Features

Enhanced delivery system†

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

  1. A dual-flex balloon
  2. A lower crossing profile4
  3. Increased catheter flexibility5
This image shows the deliverability enhancements for Onyx Frontier™ drug-eluting stent.

Product details

Onyx Frontier™ DES is different by design, featuring a single-wire design, platinum-iridium core, zotarolimus drug and BioLinx™ polymer, and a broad diameter range.

Single-wire design

Only Medtronic drug-eluting stents are made from a single wire, versus laser cutting, to enable a fluid range of motion for increased flexibility and the conformability needed for superior strut apposition.1

The Resolute Onyx™ DES sinusoid formed wire is one component in our continuous sinusoid technology.

Sinusoid formed wire

Resolute Onyx™ DES in a helical wrap formation is one component in our continuous sinusoid technology.

Helical wrap

Resolute Onyx™ DES is laser-fused.

Laser-fusion

Platinum-iridium core

The platinum-iridium core within Onyx Frontier™ DES is more visible8 than competitive DES for precise placement and follow-up disease management (while enabling greater radial strength9 with thin struts).‡

  1. Platinum-iridium core
  2. Cobalt alloy shell
This image shows the platinum-iridium core and cobalt alloy shell of Onyx Frontier™ drug-eluting stent.

Zotarolimus drug and BioLinx™ polymer

The zotarolimus drug inhibits neointimal growth10 while the BioLinx™  biocompatible polymer — the only polymer specifically designed for a DES — promotes faster healing.3

This image depicts an illustration of our BioLinx™ polymer.

MRI safety

Nonclinical testing has demonstrated that the Onyx Frontier DES 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.

Broad diameter range

Only Medtronic offers DES in 2.0 mm to 5.0 mm sizes, providing four platforms specifically designed to meet the needs of each vessel size.

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

 

 

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Complex PCI

Onyx Frontier™ DES is optimized 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, including those with high bleeding risk or who are unable to tolerate long-term DAPT with symptomatic ischemic heart disease in de novo coronary artery lesions in native coronary arteries with a reference vessel diameter of 2.0 mm to 5.0 mm and a lesion length of ≤35 mm.

One-month DAPT in high bleeding risk (HBR) patients

  • Onyx Frontier™ DES is indicated for HBR patients and labeled for one-month DAPT.§,16
  • Based on the results from the Onyx ONE Clear Analysis, which evaluated Resolute Onyx™ DES in the most complex HBR patients17
See all the Onyx ONE data

Complex patients

  • 74 years average age
  • ~50% ACS patients
  • 39% diabetes patients

Complex lesions

  • 50% moderate to severe calcified lesions
  • 79% B2/C lesions
  • 37 mm average stented length
  • > 60 mm stented length in 225 patients18

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.

Extra-large vessels
(4.50–⁠5.00 mm size)

Specifically designed with additional crowns and thicker struts19 (versus core sizes) to provide the radial strength needed for extra-large vessels.20

Extra-small vessels
(2.00–⁠2.50 mm size)

  • DES family with 2.00 mm size
  • Low crossing profile — less than 1 mm21
  • Demonstrated 2% target lesion revascularization and 0% stent thrombosis at one year in a complex, small-vessel population22
This image shows how Onyx Frontier™ drug-eluting stent expands to 6.0 mm when expanded to its maximum stent inner diameter.

Expands from 4.50  mm up to 6.00 mm while maintaining structural integrity

This image shows how Onyx Frontier™ drug-eluting stent expands to 3.5 mm when expanded to its maximum stent inner diameter.

2.00–2.50 mm expand up to 3.50 mm

Ordering information

Item number Nominal expanded
stent ID (mm)		 Nominal unexpanded
stent length (mm)		 Nominal zotarolimus
content (μg)
ONYXNG20008X 2.0 8 51
ONYXNG22508X 2.25 8 51
ONYXNG25008X 2.5 8 51
ONYXNG27508X 2.75 8 67
ONYXNG30008X 3.0 8 67
ONYXNG35008X 3.5 8 77
ONYXNG40008X 4.0 8 77
ONYXNG20012X 2.0 12 70
ONYXNG22512X 2.25 12 70
ONYXNG25012X 2.5 12 70
ONYXNG27512X 2.75 12 94
ONYXNG30012X 3.0 12 94
ONYXNG35012X 3.5 12 108
ONYXNG40012X 4.0 12 108
ONYXNG45012X 4.5 12 132
ONYXNG50012X 5.0 12 132
ONYXNG20015X 2.0 15 85
ONYXNG22515X 2.25 15 85
ONYXNG25015X 2.5 15 85
ONYXNG27515X 2.75 15 117
ONYXNG30015X 3.0 15 117
ONYXNG35015X 3.5 15 132
ONYXNG40015X 4.0 15 132
ONYXNG45015X 4.5 15 158
ONYXNG50015X 5.0 15 158
ONYXNG20018X 2.0 18 104
ONYXNG22518X 2.25 18 104
ONYXNG25018X 2.5 18 104
ONYXNG27518X 2.75 18 140
ONYXNG30018X 3.0 18 140
ONYXNG35018X 3.5 18 156
ONYXNG40018X 4.0 18 156
ONYXNG45018X 4.5 18 188
ONYXNG50018X 5.0 18 188
ONYXNG20022X 2.0 22 127
ONYXNG22522X 2.25 22 127
ONYXNG25022X 2.5 22 127
ONYXNG27522X 2.75 22 171
ONYXNG30022X 3.0 22 171
ONYXNG35022X 3.5 22 186
ONYXNG40022X 4.0 22 186
ONYXNG45022X 4.5 22 227
ONYXNG50022X 5.0 22 227
ONYXNG20026X 2.0 26 146
ONYXNG22526X 2.25 26 146
ONYXNG25026X 2.5 26 146
ONYXNG27526X 2.75 26 198
ONYXNG30026X 3.0 26 198
ONYXNG35026X 3.5 26 221
ONYXNG40026X 4.0 26 221
ONYXNG45026X 4.5 26 265
ONYXNG50026X 5.0 26 265
ONYXNG20030X 2.0 30 168
ONYXNG22530X 2.25 30 168
ONYXNG25030X 2.5 30 168
ONYXNG27530X 2.75 30 225
ONYXNG30030X 3.0 30 225
ONYXNG35030X 3.5 30 252
ONYXNG40030X 4.0 30 252
ONYXNG45030X 4.5 30 304
ONYXNG50030X 5.0 30 304
ONYXNG22534X 2.25 34 187
ONYXNG25034X 2.5 34 187
ONYXNG27534X 2.75 34 257
ONYXNG30034X 3.0 34 257
ONYXNG35034X 3.5 34 282
ONYXNG40034X 4.0 34 282
ONYXNG22538X 2.25 38 206
ONYXNG25038X 2.5 38 206
ONYXNG27538X 2.75 38 284
ONYXNG30038X 3.0 38 284
ONYXNG35038X 3.5 38 317
ONYXNG40038X 4.0 38 317

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TM* 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. 

§ Clinical data evaluating Resolute Integrity™ and Resolute Onyx™ DES apply to Onyx Frontier™ DES.

◊ Clinical data evaluating Resolute Onyx™ DES applies to Onyx Frontier™ DES

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

  1. Third-party modeling and analysis on file at Medtronic (Mortier Conformability Report). May not be indicative of clinical performance. Evaluated the following stent platforms: Resolute Onyx DES, SYNERGY DES, and XIENCE Alpine™* DES (Multi-Link 8™* BMS platform).
  2. Based on bench test data on file at Medtronic (University of Budapest Visibility Testing). May not be indicative of clinical performance. N = 3 of each DES tested (3.0 mm) Onyx Frontier DES, Orsiro®* DES, XIENCE Alpine DES, and SYNERGY DES.
  3. 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.

  1. Based on bench test data on file at Medtronic (D00339634). Compared to Resolute Onyx DES. N = 5 of each DES tested (3.0 x 18 mm).
  2. Based on bench test data on file at Medtronic (Frontier Outer Shaft Comparison Study). May not be indicative of clinical performance. Compared to Resolute Onyx catheter. N = 5 of each tested.
  3. Based on bench test data on file at Medtronic (D00339634, method D00117002). May not be indicative of clinical performance. N = 7 of each DES tested.
  4. Based on bench test data on file at Medtronic (D00339634). N = 5 of each DES tested.
  5. Based on bench test data on file at Medtronic (University of Budapest Visibility Testing). May not be indicative of clinical performance. N = 3 of each DES tested.
  6. Based on bench test data on file at Medtronic (10166182DOC). May not be indicative of clinical performance. Minimum N = 3 of each DES tested (3.0 mm) Onyx Frontier DES, Orsiro DES, XIENCE Sierra™* DES, and SYNERGY DES.
  7. 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.
  8. Third-party modeling and analysis of 3.0 mm stents on file at Medtronic (Mortier Bifurcation Simulation Report). May not be indicative of clinical performance.
  9. Bench test data on file at Medtronic (Tip Catch Test Analysis) comparing stents with rounded struts versus squared struts (3.0 mm). N = 10 of each design tested. May not be indicative of clinical performance.
  10. Based on bench test data on file at Medtronic (D00821940). May not be indicative of clinical performance. N = 3 of each stent design tested.
  11. Based on modeling of medium-vessel stents on file at Medtronic (D00642693). May not be indicative of clinical performance.
  12. Price M, Boutis L, Kirtane A, et al. One Year Clinical Outcomes in Patients with Coronary Bifurcation Lesions: Results from the Resolute Onyx Bifurcation Study. J Am Coll Cardiol. May 2021;77(18_suppl_1):965.
  13. Onyx Frontier DES Instructions for Use.
  14. Kandzari DE, Kirtane AJ, Windecker S, et al. One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients. Circ Cardiovasc Interv. November 2020;13:e009565.
  15. Kandzari D, et al. Complex PCI with 1-month DAPT in HBR Patients. Presented at TCT 2020.
  16. Based on stent design (10082545DOC).
  17. Based on bench test data on file at Medtronic (D00333762). May not be indicative of clinical performance. N = 5 of 5.0 x 18 mm tested.
  18. Based on bench test data on file at Medtronic (D00339634). May not be indicative of clinical performance. N = 5 of 2.0 x 18 mm tested.
  19. Cuellas C, et al. Use of a Zotarolimus-eluting stent for small vessel disease (DISCO 9 Study). Presented at PCR 2021.
  20. Based on bench test data on file at Medtronic (D00339634, method D00117002). May not be indicative of clinical performance. N = 7 of each DES tested (3.0 mm diameter): Onyx Frontier DES, Resolute Onyx DES, XIENCE Skypoint DES, and Orsiro Mission DES.
  21. Based on bench test data on file at Medtronic (D00339634). N = 5 of each DES tested (3.0 mm diameter): Onyx Frontier DES, Resolute Onyx DES, XIENCE Skypoint DES, and Orsiro Mission DES.

This product is licenced with Health Canada as ONYX FRONTIER ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM HC MDL #: 110235.