100%
Freedom from surgical re-intervention at 1 year (n=56)^
Freedom from reintervention with transcatheter pulmonic valve replacement (TPVR) or valve-in-valve at 1 year (n=56)^
Edwards SAPIEN 3 valve for transcatheter pulmonary valve replacement
Proven transcatheter technology
Available for the treatment of pediatric and adult patients with dysfunctional RVOT conduit or surgical bioprosthetic valve in the pulmonic position.
Delayed surgical intervention
A less invasive alternative to surgery for patients with a history of pulmonary valve intervention.
Excellent clinical performance
The major risks associated with the transcatheter pulmonic valve procedure include death, heart damage potentially requiring surgery, bleeding, blood vessel complications, and irregular heart beat.
0%
All cause death at 1 year† (n=51)^
Endocarditis at 1 year (n=51)^
Valve frame fracture at 1 year (n=51)^
98.1%
Device success rate (n=53/54)†^
93%
None/trace paravalvular regurgitation at 1 year (n=47)^
^(n=56) COMPASSION S3 trial results using the 20, 23, 26, and 29 mm SAPIEN 3 valve in dysfunctional RVOT conduit or surgical heart valve, valve implant population
† Device success is a composite of
- Single THV implanted in the desired location
- RV-PA peak-to-peak gradient < 35 mmHg post implantation
- Less than moderate PR by discharge TTE (or earliest evaluable TTE)
- Free of explant at 24 hours post implantation
Transformational valve design
Skirt
Polyethylene terephthalate (PET) outer skirt is designed to minimize paravalvular leak
Valve tissue
Utilizes the same bovine pericardium tissue and processes** as Edwards surgical valves
Frame design
Enhanced frame geometry for low profile delivery
**Excludes RESILIA tissue
Edwards commander delivery system
Features of the Edwards commander delivery system
- Allows for valve positioning and deployment
- Dual articulation for coaxiality
- Designed for precise positioning and deployment
- Compatible with 14F /16F eSheath and Gore DrySeal Sheath
Edwards eSheath introducer set
Features of the Edwards eSheath introducer set
- Hydrophilic coating designed for ease of insertion
- 14F & 16F low-profile access
- Dynamic Expansion Mechanism (DEM) for low-profile access
Edwards SAPIEN 3 transcatheter pulmonary valve (TPV) system with Alterra adaptive prestent
Fewer invasive procedures for more pulmonic patients
Continue meeting the needs of new patient populations with the Alterra adaptive prestent. It allows you to treat more pulmonic patients with severe pulmonary regurgitation with the SAPIEN 3 valve.
Delivering excellent clinical outcomes with sustained performance1
Precise predictable placement
100%
Single Alterra prestent deployed in desired location (n=60)
96.7%
Single SAPIEN 3 valve deployed in desired location (n=58/60)
Excellent Outcomes through 2 years (n=59)
0%
Mortality
0%
Endocarditis
0%
Stent fracture requiring reintervention
Sustained performance at 2 years
1.7%
Reintervention (n=59)
92.5%<=
Mild pulmonary regurgitation (n=53)
Procedural animations
Patient information
Download the Edwards SAPIEN 3 transcatheter pulmonic valve patient brochure.
References
1. Shahanavaz, Shabana Transcatheter Pulmonary Valve Implantation with the Alterra Adaptive Prestent and SAPIEN 3 Transcatheter Heart Valve: Two-Year Outcomes of the Alterra Pivotal Trial; Presented at PICS-AICS 2023, Washington DC.