Lungpacer Medical announced it has obtained premarket approval from the FDA for their leading AeroPace neurostimulation device. The AeroPace system utilizes neurostimulation through an electrode-equipped cardiovascular catheter and a software-driven management system. It periodically stimulates the phrenic nerve via the venous catheter, resulting in diaphragm contraction and strengthening for those on mechanical ventilation.
Based in Exton, Pennsylvania, Lungpacer’s AeroPace system received FDA clearance to assist with successful weaning. The system is designed to accelerate weaning, decrease ventilator dependency, and lower reintubation rates for patients aged 18 and above who have been on mechanical ventilation for over 96 hours without weaning.
According to the company’s press release, this milestone signifies the first FDA approval for such a device.
Lungpacer highlights AeroPace’s “multiple clinical benefits compared to the current standard care.” Clinical trials reveal that more patients were weaned, decreasing the likelihood of remaining on mechanical ventilation by 37% within 30 days. Additionally, the average weaning time improved by nearly three days, and the risk of 30-day reintubation fell by 60%.
Doug Evans, CEO, remarks that FDA’s approval “ushers in a new era” for liberating patients from mechanical ventilation.
“We anticipate the AeroPace System will uplift the standard of care and revolutionize the rehabilitation of mechanically ventilated patients by fostering durable independent breathing,” Evans stated. “In memory of my son, Cameron, who faced the difficulties of mechanical ventilation, we express gratitude to the committed physicians who led our three clinical trials and to the courageous patients who took part, consequently enabling faster weaning for future patients.”