Exton, Pennsylvania-based Lungpacer said this marks a major milestone in the clinical adoption of diaphragm neurostimulation for the temporary treatment of intensive care unit (ICU) patients on mechanical ventilation. Critically ill patients on mechanical ventilation often experience rapid diaphragm weakening, which can prolong ventilator dependance and complicate recovery.
AeroPace uses neurostimulation via an electrode-containing cardiovascular catheter and a software-controlled system. It delivers periodic phrenic nerve stimulation through the venous catheter. The system contracts and strengthens the diaphragm in patients on mechanical ventilation.
Lungpacer received FDA premarket approval for its flagship AeroPace system about a year ago. It also has a next-generation version called AeroNova under evaluation in a clinical trial.
The first patient commercially treated with AeroPace recovered after struggling with respiratory failure. Admitted with pneumonia, the patient had chronic COPD and already spent more than 30 days in the hospital. The patient had been on mechanical ventilation for three weeks and was unable to wean before receiving AeroPace therapy.
After 12 days of treatment using AeroPace, the patient progressed from full mechanical ventilation to support breathing independently with a trach collar, then received a discharge two days later. Throughout treatment, the patient’s X-rays, arterial blood gases and PEEP levels steadily improved. This reflected meaningful gains in lung function and overall stability.
In addition to this milestone, CMS also granted New Technology Add-on Payment (NTAP) status for AeroPace. It provides incremental reimbursement for eligible cases and facilitates adoption across hospitals.
“The transition of AeroPace from research to real-world patient care is the start of a new era in critical care,” said Doug Evans, CEO of Lungpacer Medical. “We are deeply grateful to the physicians and nurses at the hospital whose leadership and compassion made this milestone possible. Every patient who gets off ventilation faster means more days of strength, more time with family, and more hope for loved ones watching them fight to breathe on their own again. We’re committed to bringing this therapy to leading medical centers across the U.S. to help ICU patients breathe independently again and solve a major healthcare challenge.”
