Lungpacer Medical Announces PMA Submission for AeroPace® System
AeroPace is a minimally invasive transvenous diaphragm strengthening neurostimulation therapy designed for quicker liberation from mechanical ventilation
FOR IMMEDIATE RELEASE
Exton, PA – September 4, 2024 – Lungpacer Medical, a neurostimulation company developing interventional therapies to free patients from mechanical ventilation (MV) and improve diaphragm, lung, heart, and brain health, today announced that the Company’s flagship AeroPace System is under Food and Drug Administration (FDA) review in a premarket approval (PMA) application.
The investigational AeroPace System provides periodic phrenic nerve neurostimulation to strengthen the primary respiratory muscle, the diaphragm, to help people with ventilator dependence regain independent breathing faster. The RESCUE 3 study submitted with the PMA is the third in a series of studies to support FDA and international regulatory approvals. Lungpacer’s AeroPace technology previously received FDA Breakthrough Device designation and during the COVID-19 pandemic had Emergency Use Authorization (EUA) for patients on MV.
