Edwards SAPIEN 3 User Manual

2
1.0 Device Description
• Edwards SAPIEN 3 Transcatheter Heart Valve- Model 9600TFX (Figure 1)
The Edwards SAPIEN 3 Transcatheter Heart Valve is comprised of a balloon-expandable, radiopaque,
cobalt-chromium frame, trileaflet bovine pericardial tissue valve, and polyethylene terephthalate (PET)
fabric skirt. The leaflets are treated according to the Carpentier-Edwards ThermaFix process.
Table 1
Valve Size Height
20 mm 15.5 mm
23 mm 18 mm
26 mm 20 mm
29 mm 22.5 mm
Table 2
Native Valve Annulus Size
(TEE)
Native Valve Annulus Size
(CT)
Valve Size
Area
Area Derived
Diameter
16-19 mm 273 – 345 mm
2
18.6-21 mm 20 mm
18-22 mm 338 – 430 mm
2
20.7-23.4 mm 23 mm
21-25 mm 430 – 546 mm
2
23.4-26.4 mm 26 mm
24-28 mm 540 – 683 mm
2
26.2-29.5 mm 29 mm
Valve size recommendations are based on native valve annulus size, as measured by transesophageal
echocardiography (TEE) or computed tomography (CT). Patient anatomical factors and multiple imaging
modalities should be considered during valve size selection. Note: Risks associated with undersizing and
oversizing should be considered.
• Edwards Commander Delivery System (Figure 2)
The Edwards Commander delivery system is used for delivery of the Edwards SAPIEN 3 transcatheter
heart valve and consists of a Flex Catheter to aid in valve alignment to the balloon, tracking, and
positioning of the valve. The delivery system includes a tapered tip to facilitate crossing of the native
valve. The handle contains a Flex Wheel to control flexing of the Flex Catheter, and a Balloon Lock and
Fine Adjustment Wheel to facilitate valve alignment and positioning of the valve within the native annulus.
A stylet is included within the guidewire lumen of the delivery system. The Balloon Catheter has
radiopaque Valve Alignment Markers defining the working length of the balloon. A radiopaque Center
Marker in the balloon is provided to help with valve positioning. A radiopaque Triple Marker proximal to
the balloon indicates the Flex Catheter position during deployment. The inflation parameters for valve
deployment are:
Table 3
Model
Nominal
Balloon
Diameter
Nominal
Inflation
Volume
Rated Burst
Pressure
(RBP)
9600LDS20 20 mm 11 mL 7 atm
9600LDS23 23 mm 17 mL 7 atm
9600LDS26 26 mm 23 mL 7 atm
9600LDS29 29 mm 33 mL 7 atm

Edwards SAPIEN 3 Specifications

General

Product Name	Edwards SAPIEN 3
Category	Transcatheter Heart Valve
Valve Type	Balloon-expandable
Material	Bovine pericardial tissue
Frame Material	Cobalt-Chromium Alloy
Sizes	20 mm, 23 mm, 26 mm, 29 mm
Delivery System	Commander Delivery System
Regulatory Status	FDA Approved, CE Marked
Indication	Severe symptomatic aortic stenosis
Sheath Size	14F (20-23mm), 16F (26-29mm)