EVOQUE Tricuspid Valve Replacement System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- Edwards EVOQUE Tricuspid Valve Replacement System FDA PMA
- Generic Name
- Percutaneously Delivered Prostheses and Tricuspid Valves FDA PMA
Identifiers
- PMA Number
- P230013 FDA PMA
- FDA Product Code
- NPW FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The EVOQUE Tricuspid Valve Replacement System is a percutaneous transcatheter valve designed for replacement of the native tricuspid valve in patients with severe tricuspid regurgitation. It is classified as a Class III device under the generic nomenclature for Percutaneously Delivered Prostheses and Tricuspid Valves, intended to restore valve function without traditional open-heart surgery.
This system is supplied as a sterile, single-use device and is implanted via a catheter-based approach. It is authorised under FDA PMA (P230013) for use in patients with symptomatic severe tricuspid regurgitation when medical therapy is inadequate and valve replacement is deemed appropriate by a heart team. Storage and handling must comply with sterile medical device protocols.
Frequently asked questions
What is the primary clinical indication for using the EVOQUE Tricuspid Valve Replacement System in patients?
The EVOQUE Tricuspid Valve Replacement System is authorized for patients with **symptomatic severe tricuspid regurgitation (TR)** who have not responded adequately to optimal medical therapy (OMT). Its use is determined by a heart team when traditional valve replacement is deemed appropriate, allowing for catheter-based implantation without open-heart surgery.
Is the EVOQUE Tricuspid Valve Replacement System intended for reuse, or is it designed for single-use only?
The device is explicitly supplied as a **sterile, single-use system**, meaning it is not intended for reuse. Sterility and single-use compliance are critical to its clinical application, requiring adherence to sterile medical device protocols during handling and implantation.
How is the EVOQUE Tricuspid Valve Replacement System implanted, and what type of access does it require?
The EVOQUE system is implanted via a **percutaneous, catheter-based approach**, eliminating the need for traditional open-heart surgery. This minimally invasive method allows the valve to be delivered directly to the tricuspid position through vascular access, reducing recovery time and surgical risk.
What regulatory pathway was followed for FDA authorization of this device, and when was it approved?
The EVOQUE Tricuspid Valve Replacement System was authorized through the **FDA Premarket Approval (PMA) process**, with the PMA number **P230013**. The device received approval on **February 1, 2024**, following a review by the FDA’s Cardiovascular (CV) advisory committee.
Are there specific storage requirements for the EVOQUE Tricuspid Valve Replacement System to maintain its integrity?
Since the device is sterile and single-use, storage must comply with **sterile medical device protocols** to preserve its condition until use. While exact storage conditions (e.g., temperature, humidity) are not detailed in the data, standard sterile device handling practices—such as protecting from contamination and physical damage—should be followed.
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: EVOQUE Tricuspid Valve Replacement | Edwards Lifesciences, PDF Edwards EVOQUE Tricuspid Valve Replacement System, Edwards EVOQUE Tricuspid Valve Replacement System - P230013 | FDA, EVOQUE Tricuspid Valve Replacement | Edwards Lifesciences
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P230013 | Class III | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA PMA P230013 24 fields · synced Sep 18, 2026