← Back to catalogue

Edwards Sapien Transcatheter Heart Valve

FDA PMA

Class III (US FDA PMA)

PMA P100041

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
P100041 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 percutaneously delivered aortic valve prosthesis designed for transcatheter implantation. It is intended for patients with severe symptomatic native aortic valve stenosis who are deemed inoperable for open aortic valve replacement, as determined by a cardiac surgeon.

This device is supplied as a sterile, single-use system for transcatheter delivery via the femoral approach. It is classified as a Class III medical device under FDA regulations and has received FDA_PMA authorization. The valve is available in two sizes (23MM and 26MM) and is intended for use in controlled clinical settings, such as cardiac catheterization labs.

Frequently asked questions

What is the Edwards SAPIEN Transcatheter Heart Valve used for in clinical practice?

This device is specifically designed for patients with severe symptomatic native aortic valve stenosis who are deemed inoperable for traditional open-heart surgery, as determined by a cardiac surgeon. It is delivered percutaneously (via catheter) through the femoral artery to replace the diseased aortic valve, improving blood flow and relieving symptoms in patients where surgery is not an option.

How is the Edwards SAPIEN Transcatheter Heart Valve supplied, and is it reusable?

The valve is supplied as a sterile, single-use system, meaning each unit is intended for one-time use in a single patient. It comes pre-packaged for transcatheter delivery in controlled settings like cardiac catheterization labs, ensuring sterility and safety for each procedure.

What sizes are available for the Edwards SAPIEN Transcatheter Heart Valve, and how are they determined?

The valve is available in two sizes: **23MM** and **26MM**. The appropriate size is selected based on the patient’s anatomy and clinical assessment to ensure proper fit and function during transcatheter implantation.

Where and how should the Edwards SAPIEN Transcatheter Heart Valve be stored before use?

Since it is a sterile, single-use device, storage should follow manufacturer guidelines to maintain sterility. Typically, this involves keeping the sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use in a controlled clinical setting like a cardiac catheterization lab.

What regulatory pathway was followed for approval of the Edwards SAPIEN Transcatheter Heart Valve?

The device received **FDA_PMA (Premarket Approval)** authorization through a formal review process, including an expedited evaluation. The approval was granted for transcatheter delivery in patients with severe symptomatic native aortic stenosis who are inoperable for open surgery, as outlined in the **FDA_PMA (P100041)** filing.

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Edwards Lifesciences LLC
FDA Applicant
Edwards Lifesciences, LLC

Sources (1)

  • FDA PMA P100041 24 fields · synced Sep 18, 2026