Edwards SAPIEN 3 Transcatheter Heart Valve


Built upon the proven benefits of the SAPIEN valve family



Edwards SAPIEN XT Transcatheter Heart Valve
Frame design
  • Enhanced frame geometry for ultra-low delivery profile
  • High radial strength for circularity and optimal hemodynamics
Bovine pericardial tissue
  • Leaflet shape optimized
    for hemodynamics and
    durability
  • Carpentier-Edwards
    ThermaFix* process
    intended to reduce the
    risk of calcification
Low frame height
  • Respects the cardiac anatomy
Outer skirt
  • Designed to minimize paravalvular leak

Designed to minimize paravalvular leak while achieving an ultra-low delivery profile

Outer skirt
  • Polyethylene terephthalate (PET) outer skirt
    designed to minimize paravalvular leak
Frame design
  • Enhanced frame geometry and wide strut angles
    for ultra-low delivery profile

Designed for ultra-low delivery profile while maintaining radial strength for circularity

Cobalt chromium alloy frame
  • Frame material and wide strut
    angles provide fatigue resistance
    and high radial strength for
    circularity
Frame construction
  • Four rows and four columns
    of cells between each commissure
    for high radial strength
Edwards Lifesciences internal data: 2-sample t-test to determine the avg radial
strength of S3 > XT, p=0.00
Binder R., et al. Transcatheter Aortic
Valve Replacement with the SAPIEN 3:
A New Balloon-Expandable
Transcatheter Heart Valve.
JACC Cardiovasc Intv Vol. 6, No. 3, 2013.

Expanded annulus size coverage and reduced minimum access vessel diameters

23 mm 26 mm 29 mm
Edwards eSheath Introducer Set (Transfemoral) 14F 14F 16F
Minimum Access Vessel Diameter 5.5 mm 5.5 mm 6.0 mm
Edwards Certitude Sheath (Transapical) 18F 18F 21F
Native Annulus Size by TEE 18-22 mm 21-25 mm 24-28 mm
Native Annulus Area 338-430 mm2 430-546 mm2 540-683 mm2
Area-derived diameter 20.7-23.4 mm 23.4-26.4 mm 26.2-29.5 mm


* No clinical data are available with which to evaluate the long-term impact of the Carpentier-Edwards Thermafix tissue process in patients.
For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse event.

Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.
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