Edwards SAPIEN XT Transcatheter Heart Valve

Pulmonic

The First
Transcatheter Heart Valve
Approved for Pre-stented
Transannular Patches

The First Transcatheter Heart Valve Approved for Pre-stented Transannular Patches
Also approved
for use in the
pulmonic position
Conduits

Conduits

Valve in Valve

Valve-In-Valve

23, 26, and 29 mm Valve Sizes

23, 26, and 29 mm
Valve Sizes

Designed for Durability

Designed for Durability

Delayed Surgical Intervention

Sustained freedom from reintervention for patients with a history of pulmonary valve disease

Delayed Surgical Intervention
Proven Performance
95.2%
Device success rate
100%
Freedom from device or procedure related mortality out to 5 years
100%
Freedom from frame fractures out to 5 years

Approval of the 29 mm Valve Allows for Treatment of Larger Landing Zones

Sapien Valves

† 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.

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