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Edwards Sapien - Model XT - Transcatheter Heart Valves for Predictable Deployment
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
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Delayed surgical intervention
Sustained freedom from re-intervention for patients with a history of pulmonary valve disease*
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.