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.

Summary

Instructions for Use

Device Description

Edwards SAPIEN 3 Transcatheter Heart Valve

Describes the SAPIEN 3 valve components: frame, leaflets, fabric skirt.

Edwards Commander Delivery System

Explains the Commander delivery system's components and function for valve delivery.

Indications

Contraindications

Warnings

Precautions

Potential Adverse Events

Directions for Use

Required Equipment

Lists all necessary equipment for the procedure.

Valve Handling and Preparation

Details sterile technique and preparation steps for the valve.

Valve Rinsing Procedure

Prepare the Components

Mount and Crimp the Valve on the Delivery System

Valvuloplasty and Valve Delivery

Baseline Parameters

Valvuloplasty

Valve Delivery

System Removal

MR Safety

Safety and Effectiveness Results

Primary Endpoint

Key Adverse Events

Primary Endpoints

Valve Performance

Adverse Events

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)