Transcatheter pulmonic heart valves

Pulmonic

Edwards SAPIEN XT transcatheter heart valve

The first transcatheter heart valve approved for pre-stented transannular patches

Also approved for use in the pulmonic position in conduits and valve-in-valve

Pulmonic sapien xt 3 size

Edwards SAPIEN XT transcatheter heart valve

Delayed surgical intervention

Sustained freedom from re-intervention for patients with a history of pulmonary valve disease*

Proven performance

Performance Metrics

*COMPASSION trial results using the 23 mm and 26 mm SAPIEN valve, valve implant population (n=69).
^†COMPASSION trial results using the 23 mm and 26 mm SAPIEN valve, attempted implant population (n=70). Device success is defined as deployment of the valve to the target area, removal of the delivery catheter and improvement in regurgitation to none, trace, or mild.
^‡Number at risk: 1 year = 57, 2 years = 45, 3 years = 41, 4 years = 23, 5 years = 9.

Designed for durability

Sapien XT Cobalt Chromium frame, ThermaFix Tissue Process, Bovine Pericardial Tissue Leaflets

*No clinical data are available that evaluate the long-term impact of the Carpentier-Edwards ThermaFix process in patients.

Approval of the 29 mm valve allows for treatment of larger landing zones

Non-Compliant Landing Zone Diameter by 2D TEE

Video library

SAPIEN XT pulmonic procedural animation

SAPIEN XT Pulmonic post-deployment assessment

For professional use

See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

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.