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
- 1Frame design
Cobalt-chromium for high radial
strength and circularity3,10 - 2Outer sealing skirt
Designed to minimize paravalvular leak4,10
- 3Bovine 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

29mm SAPIEN 3 valve with the Alterra adaptive prestent
- 1Open cell geometry
Allows for distal placement without compromising flow to the branch pulmonary arteries5,9
- 2Nitinol frame
Delivers continuous wall apposition5,9
- 3Flared apices
Designed for migration resistance5,9
- 4Waist
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

Consistently excellent clinical outcomes, patient after patient1,2
*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
Procedural animations
Deliver excellent outcomes, potentially delay reintervention, and improve quality of life for more of your patients.1,2,7,8,9,10

References
- 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;
- 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 - BinderR. K. et al. Transcatheter Aortic Valve Replacement With the SAPIEN 3. JACC 2013;6(3):293-300
- SOP4407EL76F - SAPIEN 3 Commander Procedural Training Manual
- Edwards Alterra Prestent IFU https://eifu.edwards.com/eifu/5970f1a946e0fb00015e5f4c/DOC-0225498A.pdf
- Alterra SSED 2021 https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200015S011B.pdf
- 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
- 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)
- Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent IFU - https://eifu.edwards.com/eifu/pages/eifu-home
- Edwards Commander Delivery System Pulmonic Valve Implantation - https://eifu.edwards.com/eifu/pages/eifu-home
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


