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 optimized for complex percutaneous coronary intervention (PCI).

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

Overview

Onyx Frontier DES introduces an enhanced delivery system† and is designed to take the acute performance of Resolute Onyx™ DES even further.

Onyx Frontier DES features the same stent design differentiators that provide the conformability,1 visibility,2 fast healing,3 and size matrix you’ve come to rely on with Resolute Onyx DES.

Enhanced delivery system

Onyx Frontier DES is engineered to deliver,† featuring:

  1. A dual-flex balloon
  2. A lower crossing profile4
  3. Increased catheter flexibility5
Onyx Frontier stent with callouts to highlight the deliverability enhancements

See the latest technology in action.

Deliverability comparison — 3.0 mm DES6

(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.6

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

Stent crossing profile comparison — 3.0 mm DES7

(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.7

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

Product details

Onyx Frontier DES is different by design, featuring:

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

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

Platinum-iridium core

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

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 DES8

(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 growth10 while the BioLinx biocompatible polymer — the only polymer specifically designed for a DES — promotes faster healing.3

Illustration of the BioLinx polymer — part of Onyx Frontier DES

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 

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:

Bifurcation PCI

As the first and only DES indicated for the treatment of non-left main bifurcation lesions using the provisional technique, Onyx Frontier DES helps you:

  • Treat complex bifurcation anatomy with a highly conformable stent platform11
  • Access the side branch more easily with rounded struts12
  • Open the stent cell to the side branch while maintaining consistent scaffolding13 and strength14
Onyx Frontier drug-eluting stent (DES) inside the anatomy under fluoroscopy

Onyx Frontier DES is optimized for bifurcation, with bifurcation education built for you.

Onyx Frontier drug-eluting stent (DES) single-wire design

Unique, single-wire design provides the features necessary to optimize the main branch without compromising the side branch11

Performance goal with low event rates at one year for 24.5 percent

ONYX PAS Bifurcation Study
Beat the performance goal|| derived from contemporary trials with low event rates at one year¶15

Healthcare professional looking at a screen showing scans of a heart at the Visible Heart Lab

Portfolio of comprehensive bifurcation education to support your complex practice

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)

  • Only 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
Onyx Frontier DES 6.0 mm maximum stent inner diameter

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

Onyx Frontier DES 3.5 mm maximum stent inner diameter

2.00-2.50 mm expand up to 3.50 mm§

Chronic total occlusion (CTO)

The demonstrated deliverability,23 low crossing profile,24 and visibility2 of the Onyx DES platform make it ideal for CTOs.

More CTO resources are available on Medtronic Academy.

View CTO resources

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

Onyx one-month DAPT program

View the data on one-month DAPT in HBR patients.

Learn more

Educational resources on Medtronic Academy

Browse a variety of PCI training and education resources.

Log in here

Innovation, evidence, and education

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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.

||

Clinical data evaluating Resolute Onyx DES applies to Onyx Frontier DES. Performance goal derived from Resolute All Comers (RAC) Resolute and Xience V Arms, TRYTON trials.

Clinical data evaluating Resolute Onyx DES apply to Onyx Frontier DES.

References

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.

4

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).

5

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.

6

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.

7

Based on bench test data on file at Medtronic (D00339634). N = 5 of each DES tested.

8

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.

9

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.

10

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.

11

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.

12

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.

13

Based on bench test data on file at Medtronic (D00821940). May not be indicative of clinical performance. N = 3 of each stent design tested.

14

Based on modeling of medium-vessel stents on file at Medtronic (D00642693). May not be indicative of clinical performance.

15

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.

16

Onyx Frontier DES Instructions for Use.

17

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.

18

Kandzari D, et al. Complex PCI with 1-month DAPT in HBR Patients. Presented at TCT 2020.

19

Based on stent design (10082545DOC).

20

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.

21

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.

22

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

23

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.

24

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.