Identity
- Trade Name
- EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES FDA PMA
- Generic Name
- Aortic valve, prosthesis, percutaneously delivered FDA PMA
Identifiers
- PMA Number
- P130009 FDA PMA
- FDA Product Code
- NPT FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The SAPIEN XT Transcatheter Heart Valve is a percutaneous aortic valve prosthesis indicated for the relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis. It is designed for implantation via transcatheter delivery in patients with native anatomy appropriate for the 23, 26, or 29 mm valve system.
This device is supplied sterile and intended for single-use implantation. It is indicated for patients judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy, based on STS operative risk score >=8% or >=15% risk of mortality at 30 days. Authorization is via FDA PMA (P130009).
Frequently asked questions
What is the SAPIEN XT Transcatheter Heart Valve indicated for?
The SAPIEN XT Transcatheter Heart Valve is indicated for the relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis, defined by an aortic valve area <=1.0 cm2 or index <=0.6 cm2/m2, mean aortic valve gradient >=40 mmHg, or peak aortic-jet velocity >=4.0 m/s, and with native anatomy appropriate for the 23, 26, or 29 mm valve system.
Who manufactures the SAPIEN XT Transcatheter Heart Valve and what is its authorization status?
The SAPIEN XT Transcatheter Heart Valve is manufactured by Edwards Lifesciences LLC and has received FDA Premarket Approval (PMA) under number P130009.
Is the SAPIEN XT Transcatheter Heart Valve reusable or single-use?
The SAPIEN XT Transcatheter Heart Valve is supplied sterile and intended for single-use implantation only.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P130009 | Class III | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA PMA P130009 24 fields · synced Sep 18, 2026