Edwards SAPIEN Transcatheter Heart Valve


	Transcatheter Heart Valve

For Physicians

Transfemoral Procedural Animation

Transfemoral Valve Deployment

Product Overview

Transfemoral System Components

The PARTNER Trial: Cohort B Results (NEJM)

Important Risk Information

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For Patients

SAPIEN Transcatheter Heart Valve

A new therapy for inoperable patients with severe symptomatic native aortic valve stenosis

Bovine Pericardial Tissue
Leaflets with Carpentier-Edwards
ThermaFix Process*

Balloon-expandable
Stainless Steel Frame

Polyethylene Terephthalate
(PET) Skirt

Available in Two Sizes

Annulus Range

RetroFlex 3 Delivery System
Balloon-expandable valve technology

Transfemoral System Components

*No clinical data are available which evaluate the long-term impact of the Edwards Lifesciences tissue process in patients.

CAUTION: Federal (United States) law restricts the Edwards SAPIEN transcatheter heart valve to sale by or on the order of a physician. This device has been approved by the FDA for specific indications for use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

CAUTION: Federal (United States) law restricts the RetroFlex 3 delivery system, RetroFlex 3 introducer sheath set, RetroFlex dilator kit, RetroFlex balloon catheter, crimper, and Atrion inflation device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.