EXTON, PA — Lungpacer Medical says physicians at one of the nation’s largest healthcare systems have completed the first commercial procedures using its FDA-approved AeroPace System, marking a pivotal step in bringing diaphragm neurostimulation into routine intensive care.
The AeroPace device is designed to help critically ill patients on mechanical ventilation regain the ability to breathe independently. It works by activating and strengthening the diaphragm through a minimally invasive, temporary transvenous neurostimulation approach. Prolonged ventilation often leads to rapid diaphragm weakening, a major factor behind failed weaning attempts and extended ICU stays.
Lungpacer said the first patient treated commercially had severe respiratory failure complicated by pneumonia and chronic obstructive pulmonary disease, after spending more than a month hospitalized and three weeks on a ventilator. Following twelve days of AeroPace therapy, the patient progressed from full ventilator support to independent breathing with a tracheostomy collar and was discharged home two days later, shortly before Thanksgiving. During treatment, clinical indicators including imaging, blood gases, and airway pressure requirements showed steady improvement.
Company executives say the case illustrates the system’s potential to change outcomes for a patient population that consumes significant ICU resources and faces high risks of complications. By restoring diaphragm function, AeroPace aims to shorten time on ventilation, reduce recovery setbacks, and improve the odds of durable respiratory independence.
Chief Executive Officer Doug Evans called the first commercial use a turning point for critical care, saying the technology’s move from research settings to bedside practice opens the door to broader adoption. He said each successful weaning represents not just lower costs and shorter ICU stays, but a meaningful improvement in quality of life for patients and families.
The AeroPace System holds FDA Breakthrough Device designation and has received premarket approval for improving ventilator weaning success. Adoption may also be supported by reimbursement policy. The Centers for Medicare & Medicaid Services granted the system New Technology Add-on Payment status beginning October 1, 2025, providing additional reimbursement for eligible hospital cases.
With regulatory clearance and payment support in place, Lungpacer says it is working to expand availability of AeroPace across leading U.S. medical centers, positioning diaphragm neurostimulation as a new tool in the fight to reduce prolonged mechanical ventilation in ICUs nationwide.
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