Edwards SAPIEN 3 User Manual

1
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.

Edwards SAPIEN 3 Specifications

General

Brand	Edwards
Model	SAPIEN 3
Category	Medical Equipment
Language	English