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, 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.
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.
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