FDA grants premarket approval to diaphragm activation system for ventilated adults

The FDA has granted premarket approval to the AeroPace System, which helps mechanically ventilated adults of at least 96 hours wean off ventilation through temporary diaphragm activation, according to a company press release.

The release notes that the AeroPace System (Lungpacer Medical) is used in combination with the AeroPace Catheter.

By specifically stimulating the phrenic nerves, the release and the Dec. 6 FDA roundup state that the system strengthens a patient’s diaphragm, leading to better breathing and weaning outcomes.

When assessed against the current standard of care, the AeroPace System has been found to increase the number of patients weaned, cut the time to wean by almost 3 days and lower the risks for mechanical ventilation use (37% decrease) and reintubation (60% decrease) at the 30-day mark, according to the release.

“[The] approval of our AeroPace System, an FDA designated Breakthrough Device, is transformative for respiratory care and represents a new era in which clinicians will now have a treatment option for critical care patients who have failed to wean from mechanical ventilation,” Doug Evans, PE, CEO of Lungpacer, said in the release. “We expect that the AeroPace System will improve the standard of care and transform the future care of mechanically ventilated patients by helping them recover durable independent breathing.”

Reference:

• FDA roundup: December 6, 2024. https://www.fda.gov/news-events/press-announcements/fda-roundup-december-6-2024. Published Dec. 6, 2024. Accessed Dec. 9, 2024.