Lungpacer Medical Announces First Patient Enrollment in AERO-PAS Post-Approval Study of the AeroPace® System
Sutter Health's California Pacific Medical Center in San Francisco opens the multicenter study, which will evaluate the
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EXTON, Pa., Nov. 12, 2026 (GLOBE NEWSWIRE) — Lungpacer Medical today announced the first patient enrollment in AERO-PAS, a post-approval multicenter study of the AeroPace® System (ClinicalTrials.gov: NCT07477054). The first site is Sutter Health’s California Pacific Medical Center (CPMC) in San Francisco, where the study will be led by Principal Investigator George S. Horng, MD, Medical Director of Critical Care Services at CPMC.
AERO-PAS is a prospective, single-arm, multicenter study that will enroll up to 120 adults who have been on mechanical ventilation for at least 96 hours and have not weaned. The study will capture additional safety and effectiveness data of AeroPace through 30 days in routine clinical practice, building on the randomized RESCUE-3 pivotal trial which supported the therapy’s FDA premarket approval.
Patients who require prolonged mechanical ventilation are among the most resource-intensive in the hospital. When a ventilator breathes for the patient, the diaphragm can weaken quickly from disuse, a condition known as ventilator-induced diaphragm dysfunction, which makes it harder for patients to breathe on their own. AeroPace is delivered through a catheter placed in a central vein that stimulates the phrenic nerves to contract and exercise the diaphragm, helping to strengthen it and facilitate weaning from mechanical ventilation.
“Patients who fail to wean after several days on the ventilator are some of the most challenging we care for, and every additional ventilator day adds risk for the patient and strain on the ICU,” said Dr. Horng. “AeroPace gives us a new way to address diaphragm weakness directly and improve weaning success, rather than simply waiting for patients to recover. We are pleased to offer this therapy to our patients at CPMC and to contribute to real-world data that will help define how diaphragm neurostimulation fits into routine critical care.”
“Activating the first AERO-PAS site is an important milestone in building the real-world evidence base for AeroPace,” said Doug Evans, President and CEO of Lungpacer Medical. “RESCUE-3 showed that diaphragm neurostimulation can help patients who are struggling to come off the ventilator, demonstrating 43% faster weaning and a three-day average reduction of ventilator time in the ICU per patient. AERO-PAS will show clinicians, hospital leaders and payors how that benefit carries into everyday ICU practice. We are proud to begin this work with Dr. Horng and the critical care team at Sutter Health, a system that shares our commitment to helping patients breathe on their own again.”
Additional sites are expected to be activated in the coming months, with study enrollment completion anticipated in 2028.
About Lungpacer Medical
Lungpacer Medical is a medical technology company focused on improving outcomes for critically ill patients through innovative neurostimulation therapies designed to restore natural physiology, accelerate recovery, and reduce the burden of care.
The AeroPace System is indicated to improve weaning success in patients on mechanical ventilation for at least 96 hours. The system delivers temporary transvenous stimulation of the phrenic nerves to activate the diaphragm, integrating into standard ICU workflows without requiring surgical implantation. Not for use in patients with implantable electronic devices. ISI: https://go.lungpacer.com/isi
Learn more at Lungpacer.com and connect on LinkedIn.
Media Contact: media@lungpacer.com
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