# NPT · Aortic Valve, Prosthesis, Percutaneously Delivered

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/CV-misc/NPT

## Overview

- **Product Code:** NPT
- **Device Name:** Aortic Valve, Prosthesis, Percutaneously Delivered
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes
- **Life-sustaining:** yes

## Identification

To replace a patient's aortic heart valve.  They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P250024](https://fda.innolitics.com/submissions/CV/CV-misc/NPT/P250024.md) | Trilogy Transcatheter Heart Valve System | JenaValve Technology, Inc. | Mar 17, 2026 | APPR |
| [P190023](https://fda.innolitics.com/submissions/CV/CV-misc/NPT/P190023.md) | Portico Transcatheter Aortic Valve Implantation System | ABBOTT MEDICAL | Sep 17, 2021 | APPR |
| [P180029](https://fda.innolitics.com/submissions/CV/CV-misc/NPT/P180029.md) | LOTUS Edge Valve System | Boston Scientific Corporation | Apr 23, 2019 | APWD |
| [P140031](https://fda.innolitics.com/submissions/CV/CV-misc/NPT/P140031.md) | SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES | Edwards Lifesciences, LLC | Jun 17, 2015 | APPR |
| [P130009](https://fda.innolitics.com/submissions/CV/CV-misc/NPT/P130009.md) | EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES | Edwards Lifesciences, LLC | Jun 16, 2014 | APPR |
| [P130021](https://fda.innolitics.com/submissions/CV/CV-misc/NPT/P130021.md) | MEDTRONIC COREVALVE SYSTEM | Medtronic, Inc. | Jan 17, 2014 | APPR |
| [P110021](https://fda.innolitics.com/submissions/CV/CV-misc/NPT/P110021.md) | EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES | Edwards Lifesciences, LLC | Oct 19, 2012 | APWD |
| [P100041](https://fda.innolitics.com/submissions/CV/CV-misc/NPT/P100041.md) | EDWARDS SAPIEN TRANSCATHETER HEART VALVE  AND ACCESSORIES | Edwards Lifesciences, LLC | Nov 2, 2011 | APWD |

## Top Applicants

- Edwards Lifesciences, LLC — 4 clearances
- ABBOTT MEDICAL — 1 clearance
- Boston Scientific Corporation — 1 clearance
- JenaValve Technology, Inc. — 1 clearance
- Medtronic, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CV/CV-misc/NPT](https://fda.innolitics.com/submissions/CV/CV-misc/NPT)

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