Lungpacer Enrolls First Patient in Post-Approval Study of Device to Help Patients Leave Ventilators
The AERO-PAS study will follow up to 120 adults who have not been able to come off mechanical ventilation after at least four days. Lungpacer says the first patient enrolled at a San Francisco hospital.
Lungpacer Medical said Thursday that the first patient has enrolled in a post-approval study of its AeroPace system, a device designed to help patients who are having difficulty coming off a ventilator.
The first study site is Sutter Health's California Pacific Medical Center in San Francisco. The AERO-PAS study will enroll up to 120 adults who have received mechanical ventilation for at least 96 hours and have not been weaned from it, according to the company.
The prospective, single-arm study will collect additional safety and effectiveness data through 30 days in routine clinical care. It follows the RESCUE-3 trial that supported the device's FDA premarket approval. This announcement marks the start of enrollment, not new results from the post-approval study.
AeroPace uses a catheter placed in a central vein to stimulate the phrenic nerves, causing the diaphragm to contract. The approach is intended to address diaphragm weakness that can develop when a ventilator does the work of breathing for an extended period.
The company said more study sites are expected to open in the coming months, with enrollment expected to finish in 2028. The system is indicated to improve weaning success after at least 96 hours of mechanical ventilation and is not for use in patients with implantable electronic devices.