Edwards SAPIEN 3

3
Figure 2: Edwards Commander Delivery System
• Qualcrimp Crimping Accessory
The Qualcrimp crimping accessory (packaged with the Edwards Commander delivery system) is used
during crimping of the valve.
• Edwards eSheath Introducer Set
Refer to the Edwards eSheath Introducer Set instructions for use for device description.
• Edwards Crimper
Refer to the Edwards Crimper instructions for use for device description.
2.0 Indications
The Edwards SAPIEN 3 transcatheter heart valve, Model 9600TFX, and accessories are indicated for
relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic
stenosis who are judged by a Heart Team, including a cardiac surgeon, to be at intermediate or greater
risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 3% at 30 days, based on the
Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS
risk calculator).
3.0 Contraindications
The valve and delivery systems are contraindicated in patients who cannot tolerate an
anticoagulation/antiplatelet regimen or who have active bacterial endocarditis or other active infections.
4.0 Warnings
• Observation of the pacing lead throughout the procedure is essential to avoid the potential risk of
pacing lead perforation.
• There may be an increased risk of stroke in transcatheter aortic valve replacement procedures, as
compared to balloon aortic valvuloplasty or other standard treatments in high or greater risk patients.
• The devices are designed, intended, and distributed for single use only. Do not resterilize or reuse
the devices. There are no data to support the sterility, nonpyrogenicity, and functionality of the
devices after reprocessing.
• Incorrect sizing of the valve may lead to paravalvular leak, migration, embolization and/or annular
rupture.
• Accelerated deterioration of the valve may occur in patients with an altered calcium metabolism.
• Prior to delivery, the valve must remain hydrated at all times and cannot be exposed to solutions
other than its shipping storage solution and sterile physiologic rinsing solution. Valve leaflets