FDA Approves Lungpacer Medical’s AeroPace Neurostimulation System

Lungpacer Medical has earned U.S. Food and Drug Administration (FDA) premarket approval (PMA) for its flagship AeroPace system.

Aeropace leverages neurostimulation via an electrode-containing cardiovascular catheter and software-controlled system to contract and strengthen the diaphragm in patients who are on mechanical ventilation. Its approved indication is to improve weaning success—increase weaning, reduce ventilator days, and reduce intubation—in adult patients on mechanical ventilation ≥96 hours and who have not weaned.

The company cited several clinical advantages of Aeropace compared to the current standard of care. More patients were weaned, reducing the risk of staying on mechanical ventilation at 30 days by up to 37%. Weaning was faster by almost three days, and reintubation risk at 30 days was reduced by up to 60%.

“Today’s 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,” said Doug Evans, Lungpacer Medical’s CEO. “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. In memory of my son, Cameron, who endured the challenges of mechanical ventilation, we are all grateful to the dedicated physicians who conducted our three clinical trials and to the brave patients who participated in them such that their efforts will help many more patients to wean more quickly.”

AeroPace is contraindicated in patients with active implanted cardiac pacemakers, defibrillators or other implantable electronics within proximity to the device, having not been clinically evaluated for safety with these implantable devices.