Edwards SAPIEN 3 User Manual (English)

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Edwards SAPIEN 3 Transcatheter Heart Valve

with the Edwards Commander Delivery System

Instructions for Use

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.

Implantation of the transcatheter heart valve should be performed only by physicians who have

received Edwards Lifesciences training. The implanting physician should be experienced in

balloon aortic valvuloplasty.

Please verify that you have the latest version of the instructions for use prior to using the device

by visiting http://THVIFU.edwards.com or by calling 1.800.822.9837. In order to access the

instructions for use, an IFU Code will be required.

STERILE: The valve is supplied sterilized with glutaraldehyde solution. The delivery system,

eSheath introducer set, and crimper are supplied sterilized with ethylene oxide gas.

Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, EDWARDS COMMANDER,

Edwards eSheath, Edwards SAPIEN, Edwards SAPIEN 3, eSheath, PARTNER, PARTNER II, Qualcrimp,

SAPIEN, SAPIEN 3, TFX, and ThermaFix are trademarks of Edwards Lifesciences Corporation. All other

trademarks are the property of their respective owners.

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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)