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Edwards SAPIEN 3 pulmonic portfolio:

Pulmonic
Edwards SAPIEN 3 pulmonic portfolio

Where heart valve innovation and living life to the fullest meet

Your patients deserve the proven outcomes and durable performance the SAPIEN 3 valve delivers: potentially reducing reinterventions so they can live their lives to the fullest.1,2

SAPIEN 3 valve

SAPIEN 3 valve

  1. 1
    Frame design


    Cobalt-chromium for high radial
    strength and circularity3,10

  2. 2
    Outer sealing skirt


    Designed to minimize paravalvular leak4,10

  3. 3
    Bovine percardial tissue


    Backed by 40+ years of tissue innovation4,10


Proven technology that extends SAPIEN 3 valve benefits to more patients

The Alterra adaptive prestent—accurate, secure placement for an expanded group of patients1,5,6,8,9

Alterra

29mm SAPIEN 3 valve with the Alterra adaptive prestent

  1. 1
    Open cell geometry


    Allows for distal placement without compromising flow to the branch pulmonary arteries5,9

  2. 2
    Nitinol frame


    Delivers continuous wall apposition5,9

  3. 3
    Flared apices

    Designed for migration resistance5,9

  4. 4
    Waist


    With radiopaque markers for placement
of the 29mm SAPIEN 3 valve5,9

Engineered to be minimally invasive and potentially reduce reinterventions—so patients can maximize their time away from surgery and keep moving forward.6,8,9,10

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Consistently excellent clinical outcomes, patient after patient1,2

Consistently excellent clinical outcomes, patient after patient

*In patients with dysfunctional right ventricular outflow tract (RVOT) conduit or surgical bioprosthetic valve.


†In patients with native or surgically repaired right ventricular outflow tract.

Delivery systems that offer controlled, predictable, and precise positioning5,9,10

Ready to adapt and adjust based on patient needs

1 / 3
Alterra Delivery System
SAPIEN 3 Pulmonic Delivery System
Edwards Commander Delivery System
Alterra Delivery System
SAPIEN 3 Pulmonic Delivery System
Edwards Commander Delivery System

Alterra Delivery System

Recapture and reposition with ergonomic control, smooth tracking, and a system developed specifically for the Alterra adaptive prestent.5,9

SAPIEN 3 Pulmonic valve Delivery System

Covered system designed to track through complex anatomies and deliver the 29mm SAPIEN 3 valve into the Alterra adaptive prestent.9

Edwards Commander Delivery System

Dual articulation designed for precise positioning and deployment of the SAPIEN 3 valve.10

Procedural animations

Deliver excellent outcomes, potentially delay reintervention,
and improve quality of life for
more of your patients.1,2,7,8,9,10

SAPIEN 3 and Alterra

References

  1. Aboulhosn J. et al. Five-year Results from the COMPASSION S3 Trial Treatment of Patients with Dysfunctional RVOT Conduit or Previously Implanted Pulmonic Valve with SAPIEN 3 Trancatheter Heart Valve;
  2. Presented at PICS 2024, San Diego, CA.
    2. Torres A. J. et al. Transcatheter Pulmonary Valve Implantation with the Alterra Adaptive Prestent and SAPIEN 3 Transcatheter Heart Valve: Three-year Pooled Outcomes of the ALTERRA trial. Presented at PICS 2025
  3.  BinderR. K. et al. Transcatheter Aortic Valve Replacement With the SAPIEN 3. JACC 2013;6(3):293-300
  4.  SOP4407EL76F - SAPIEN 3 Commander Procedural Training Manual
  5.  Edwards Alterra Prestent IFU https://eifu.edwards.com/eifu/5970f1a946e0fb00015e5f4c/DOC-0225498A.pdf
  6.  Alterra SSED 2021 https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200015S011B.pdf
  7.  Zahn E. et al. Alterra Adaptive Prestent and SAPIEN 3 THV for Congenital Pulmonic Valve Dysfunction: 5-year Outcomes of the ALTERRA Early Feasibility Study. Presented at PICS 2024
  8.  Dimas V.V. et al. Multicenter Pivotal Study of the Alterra Adaptive Prestent for the Treatment of Pulmonary Regurgitation. JACC Cardio. Interv. 2024;17(19)
  9.  Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent IFU - https://eifu.edwards.com/eifu/pages/eifu-home
  10.  Edwards Commander Delivery System Pulmonic Valve Implantation - https://eifu.edwards.com/eifu/pages/eifu-home
Important safety information

Important safety information

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).
PP--EU-11618 v1.0