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SAPIEN 3 Ultra transcatheter heart valve

SAPIEN 3 Ultra
SAPIEN 3 Ultra
SAPIEN 3 Ultra
Structural Heart THV banner image
Structural Heart THV banner image
Structural Heart THV banner image

Built upon the proven SAPIEN platform, the SAPIEN 3 Ultra transcatheter heart valve is designed with your patient's future needs in mind.

Taller, textured outer skirt1

  • Approximately 40% increased outer skirt*
  • Textured PET material
  • 14F sheath compatibility

*Compared to the Edwards SAPIEN 3 valve

Edwards Commander Delivery System
Edwards Commander Delivery System
Edwards Commander Delivery System

Edwards Commander Delivery System: For predictable, proven results2

Delivering your strategy for lifetime management
through the eSheath+ Introducer Set

Delivering your strategy for lifetime
Delivering your strategy for lifetime
Delivering your strategy for lifetime
Controlled, low-profile vascular access for today's transcatheter aortic valve patients. Thoughtfully designed to:
  • Consistently reduce current and future patient complications
    (i.e vascular bleeding)3,4
  • Improve and simplify the implanter's experience
  • Accelerate the preparation phase for the Heart Team

TAVI procedural animation using the SAPIEN 3 Ultra system


Learn more about SAPIEN 3 Ultra TAVI* clinical evidence

*TAVI = Transcatheter Aortic Valve Implantation 

References

1. Nazif,et al. Real-World Experience With the SAPIEN 3 Ultra Transcatheter Heart Valve. 2021
2. Webb J, Gerosa G, Lefèvre T, et al. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 2014;64(21):2235-2243.
3. Thourani VH, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet. 2016 May 28;387(10034):2218-25)
4. Mack MJ, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705)
5.  Mack MJ, et al. Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years. N Engl J Med. 2023 Nov 23;389(21):1949-1960.
6. Madhavan MV, et al. Outcomes of SAPIEN 3 Transcatheter Aortic Valve Replacement Compared With Surgical Valve Replacement in Intermediate-Risk Patients. J Am Coll Cardiol.
   2023 Jul 11;82(2):109-123.
†Data on file at Edwards Lifesciences

Medical device for professional use.

For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).

Edwards, Edwards Lifesciences, the stylized E logo, Commander, Edwards Commander, eSheath, eSheath+, SAPIEN, SAPIEN 3, SAPIEN 3 Ultra, and ThermaFix are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners. 

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