Lungpacer Medical's AeroPace System, a novel neurostimulation therapy designed to aid in weaning patients from mechanical ventilation, has received premarket approval from the U.S. Food and Drug Administration (FDA). This approval marks a significant advancement in respiratory care, offering a new approach to improve weaning outcomes for adults who have been on mechanical ventilation for an extended period. The AeroPace System works by stimulating the phrenic nerves, which control the diaphragm, to strengthen the muscle and improve breathing capabilities.
How AeroPace Works
The AeroPace System utilizes a cardiovascular catheter equipped with electrodes and a software-controlled system to deliver periodic phrenic nerve stimulation. This stimulation contracts and strengthens the diaphragm, the primary muscle responsible for breathing. The system is indicated for patients aged 18 years or older who have been on mechanical ventilation for 96 hours or longer and have not been successfully weaned.
Clinical Evidence and Benefits
Clinical evaluations of the AeroPace System have demonstrated several advantages over the current standard of care. Key findings include:
- Increased Weaning Success: A higher proportion of patients were successfully weaned from mechanical ventilation.
- Reduced Ventilator Days: The time to wean was reduced by nearly three days.
- Lower Reintubation Risk: The risk of reintubation at 30 days was reduced by up to 60%.
- Decreased Risk of Prolonged Ventilation: The risk of remaining on mechanical ventilation at 30 days was reduced by up to 37%.
Doug Evans, CEO of Lungpacer Medical, stated that the FDA approval "represents a new era" in respiratory care, providing clinicians with a new treatment option for critical care patients who have failed to wean from mechanical ventilation. He anticipates that the AeroPace System will improve the standard of care and transform the future management of mechanically ventilated patients by helping them recover durable independent breathing.
Expert Commentary
Ewan Goligher, MD PhD, Associate Professor of Medicine and Physiology, University of Toronto, commented on the importance of maintaining diaphragmatic integrity during mechanical ventilation, noting that the majority of patients requiring mechanical ventilation develop significant diaphragm muscle weakness. He added, "These data indicate that Lungpacer diaphragm pacing technology can accelerate recovery for patients who have difficulty weaning from mechanical ventilation."
Richard Branson, Professor at the University of Cincinnati, highlighted that common techniques of mechanical ventilation tend to ignore or disadvantage the diaphragm. He stated, "Diaphragmatic pacing using AeroPace therapy is the first approved intervention proven to shorten the liberation process. This is a novel, effective step forward reducing patient time spent on the ventilator."
Contraindications
The AeroPace System is contraindicated in patients with active implanted cardiac pacemakers, defibrillators, or other implantable electronics within proximity to the device, as safety has not been clinically evaluated with these implantable devices.
