AeroPace System
by Lungpacer Medical USA, Inc. United States PMA
PMA P240012 Product code SDL
Overview
The AeroPace System is a Transvenous Temporary Phrenic Nerve Stimulator, classified as a Class III medical device. It is designed to stimulate the phrenic nerve to assist diaphragmatic contraction, aiding patients in the weaning process from mechanical ventilation.
This device is intended for use in patients aged 18 years or older who have been mechanically ventilated for at least 96 hours and have not yet successfully weaned. Supplied sterile and intended for single-use, it is regulated under an FDA PMA (Premarket Approval) with PMA number P240012, approved on December 4, 2024. The system is categorized under product code SDL and is manufactured by LungPacer Medical USA, Inc.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP240012 | Date4 Dec 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Transvenous temporary phrenic nerve stimulator
- PMA Number
- FDA Product Code
- SDL
- Device Class
- Class III
- Advisory Committee
- Anesthesiology
- FDA Decision
- APPR Approved
Other devices from Lungpacer Medical USA, Inc.
Questions
What is the AeroPace® System designed to help patients achieve during mechanical ventilation weaning?
The AeroPace® System is specifically designed to assist patients aged 18 and older who have been on mechanical ventilation for at least 96 hours but have not yet successfully weaned. It works by stimulating the phrenic nerve to help facilitate diaphragmatic contraction, which can improve weaning success, reduce the number of ventilator days, and lower the risk of reintubation.
Is the AeroPace® System intended for repeated use, or is it meant to be used once and then discarded?
The AeroPace® System is supplied sterile and explicitly intended for **single-use only**. This means it should not be reused after a single procedure, ensuring patient safety and maintaining sterility standards.
What regulatory pathway does the AeroPace® System follow, and what does that mean for its use?
The AeroPace® System follows the **FDA Premarket Approval (PMA)** pathway, which is the most stringent regulatory route for Class III devices. This means it has undergone rigorous clinical evaluation to demonstrate safety and effectiveness before approval. The system carries PMA number **P240012**, approved on December 4, 2024, ensuring it meets high standards for use in clinical settings.
What age group is the AeroPace® System intended for, and what is the minimum duration of mechanical ventilation required before use?
The AeroPace® System is intended for patients **18 years or older** who have been on mechanical ventilation for **at least 96 hours** but have not yet successfully weaned. This criteria ensures it is used in appropriate clinical scenarios where diaphragmatic support is needed.
How is the AeroPace® System categorized in terms of medical specialty, and what does that imply for its use?
The system is associated with the **Anesthesiology** advisory committee, though its primary clinical application is in critical care or respiratory support settings. This classification reflects its role in assisting with ventilator weaning, a process often overseen by anesthesiologists or critical care specialists, though it is not limited to their exclusive use.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA PMA P240012