Resolute Onyx Drug-eluting Stent Optimized for Complex PCI

Alert Indications, Safety, and Warnings

Overview

     

High Bleeding Risk Patients

Resolute Onyx™ DES is indicated for high bleeding risk (HBR) patients with 1-month DAPT labeling, based on the Onyx ONE Clear Analysis, which studied the most complex HBR patients for greater confidence in short DAPT decisions.

Complex Patients1

  • 74 years average age
  • Nearly 50% with ACS
  • 39% with diabetes

Complex Lesions1

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

Chronic Total Occlusion

Resolute Onyx DES offers exceptional deliverability and enhanced visibility2 for complex chronic total occlusion (CTO) cases.

CTO Performance Backed by Evidence†3

  • 92.3% procedural success
  • 96.2% technical success
  • 1.1% TLR at one year
  • 0.6% stent thrombosis at one year

See More about CTO

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Small Vessels

When it comes to treating small vessels, Resolute Onyx DES offers the lowest crossing profile for superior deliverability‡2 and is engineered to expand from 2.0 mm to 3.50 mm.§4

The Most Deliverable Stent‡2

Lower Is Better
Average Force (gF) 

Graph showing Resolute Onyx DES deliverability compared to others

Engineered to Expand

Our smallest DES expands from 2.0–3.50 mm
and features low foreshortening when
expanded to 3.50 mm.§4,5

Graphic demonstrating Resolute Onyx 2.00 mm stent, which can now expand up to 3.50 mm

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Extra-Large Vessels

Resolute Onyx DES is designed for extra-large vessels and was the first DES to offer 4.50 and 5.00 mm sizes, which can now expand up to 6.00 mm.§4 It sustains structural strength and coating integrity when overexpanded and its 5 Fr compatibility is designed with the transradial approach in mind.2

Specifically Engineered for Extra-large Vessels3

The Resolute Onyx DES 4.5 and 5.0 mm sizes feature increased strut thickness and additional crowns compared to core size offerings, helping meet the needs of extra-large vessels.

Resolute Onyx DES Strut Thickness

Illustration showing thicker struts for Resolute Onyx DES 4.5 and 5.0 mm sizes versus its smaller, 2.00-4.00 mm sizes

Resolute Onyx DES Crowns

Illustration showing 9.5 crowns available on Resolute Onyx 3.5-4.0mm size stents and 10.5 crowns available on Resolute Onyx 4.5 and 5.0 mm size stents.

Sustained Radial Strength2

Higher Is Better||

Graph showing Resolute Onyx DES maintains higher compression resistance compared to others

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Diabetic Patients

In recent Medtronic studies, diabetes patients make up over 35% of the coronary stents implanted.1,6

The Medtronic DES portfolio was the first indicated for CAD treatment in patients with diabetes.2

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Additional Resources

Educational Resources on Medtronic Academy

Log in to Medtronic Academy to browse a variety of Coronary education, training, and resources.

Log in to Medtronic Academy

Resolute

Onyx DES

Resolute Onyx DES is designed to be placed inside a diseased coronary artery to keep the artery open so that blood can access the heart.

View Resolute Onyx DES

Innovation, Evidence, and education

View our latest product and therapy innovations, clinical evidence, and educational offerings for the interventional cardiology space.

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*

Third-party brands are trademarks of their respective owners.

†

Endpoints presented from the PERSPECTIVE study (NCT02884206) were not powered.

‡

Testing performed on smallest diameters available for Abbott Xience Alpine™*, Biotronik Orsiro™*, Boston Scientific Promus Premier™*, Boston Scientific Synergy™*, Medtronic Resolute Integrity™, and Medtronic Resolute Onyx coronary stents.

§

The Resolute Onyx stents should not be expanded to a diameter beyond the maximum labeled diameter listed per the IFU. Post-dilatation required for overexpansion.

||

Values shown in N/mm/mm. Testing measures the resistance to radial deformation.

References

1

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(11):e009565.

2

Based on bench test data on file at Medtronic. May not be indicative of clinical performance.

3

Kandzari DE, Lembo NJ, Carlson HD, et al. Procedural, clinical, and health status outcomes in chronic total coronary occlusion revascularization: Results from the PERSPECTIVE study. Catheter Cardiovasc Interv. September 1, 2020;96(3):567-576.

4

Resolute Onyx DES, Instructions for Use.

5

Medtronic data on file.

6

Windecker S, Latib A, Kedhi E, et al. Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk. N Engl J Med. March 26, 2020;382(13):1208-1218.