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Edwards Sapien Transcatheter Heart Valve and Transapical and Transfemoral Accessories

FDA PMA

Class III (US FDA PMA)

PMA P110021

by Edwards Lifesciences LLC

Identity

Trade Name
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES FDA PMA
Generic Name
Aortic valve, prosthesis, percutaneously delivered FDA PMA

Identifiers

PMA Number
P110021 FDA PMA
FDA Product Code
NPT FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APWD FDA PMA

The Edwards Sapien transcatheter heart valve is a percutaneous aortic valve prosthesis indicated for transapical and transfemoral delivery in patients with severe symptomatic calcified native aortic valve stenosis. It is supplied as model 9000TFX in sizes 23 mm and 26 mm, accompanied by the Ascendra balloon catheter for transapidal delivery and the Retroflex 3 delivery system for transfemoral delivery.

This device is intended for use in patients with ejection fraction >= 20% who have been evaluated by a heart team and are either inoperable or at high risk for surgical aortic valve replacement, with a Society of Thoracic Surgeons operative risk score >= 8% or judged to be at >=15% mortality risk. It is a Class III device authorized under FDA PMA P110021 and is supplied sterile for single-use implantation.

Frequently asked questions

What sizes are available for the Edwards Sapien transcatheter heart valve model 9000TFX?

The Edwards Sapien transcatheter heart valve model 9000TFX is available in sizes 23 mm and 26 mm, as specified in the approval documentation for both transapical and transfemoral delivery.

Is the Edwards Sapien transcatheter heart valve approved for use in patients with severe aortic insufficiency?

No, the device is indicated only for patients with severe symptomatic calcified native aortic valve stenosis without severe aortic insufficiency, as stated in the indications for both transapical and transfemoral delivery pathways.

What delivery systems are included with the Edwards Sapien transcatheter heart valve and accessories?

The system includes the Ascendra balloon catheter for transapical delivery and the Retroflex 3 delivery system for transfemoral delivery of the Edwards Sapien transcatheter heart valve model 9000TFX.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Edwards Lifesciences – the leading global structural heart innovation ..., Edwards Lifesciences – the leading global structural heart innovation ..., Edwards Lifesciences – Wikipedia, Edwards Lifesciences - Wikipedia, Edwards Lifesciences - Herzmedizin.de

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Edwards Lifesciences LLC
FDA Applicant
Edwards Lifesciences, LLC

Sources (1)

  • FDA PMA P110021 24 fields · synced Sep 18, 2026