EXTON, PA — Lungpacer Medical has announced that its innovative AeroPace System is currently under review by the Food and Drug Administration (FDA) as part of a premarket approval (PMA) application. This development marks a significant step forward for the system, which aims to assist patients who rely on mechanical ventilation by strengthening the diaphragm, the primary respiratory muscle.
The AeroPace System works by providing periodic neurostimulation to the phrenic nerve, effectively training the diaphragm to enhance its strength. This approach is particularly crucial for patients whose diaphragms have weakened due to prolonged ventilator use, which can reduce muscle strength by over 50% within a day. By acting as a “personal trainer” for the diaphragm, the AeroPace System aims to help patients regain the ability to breathe independently and break free from the dependence on mechanical ventilators.
Lungpacer’s technology has already shown promise, having received FDA Breakthrough Device designation and Emergency Use Authorization (EUA) during the COVID-19 pandemic for use in patients on mechanical ventilation. The RESCUE 3 study, submitted with the PMA application, is the latest in a series of investigations supporting regulatory approval, underlining the potential benefits of the AeroPace System.
Doug Evans, CEO of Lungpacer Medical, highlighted the system’s potential impact, stating, “This emerging research underscores the clinical potential of AeroPace therapy in providing a new option to alleviate the negative impacts of mechanical ventilation by restoring diaphragm strength and expediting ventilator independence. The AeroPace System has the potential to positively improve the standard of care and transform the future care for ventilated patients.”
Further emphasizing the system’s promise, Dr. Ali Ataya, a Principal Investigator in the RESCUE 3 study and an Associate Professor of Medicine at the University of Florida, expressed optimism about the impact of AeroPace Therapy. “We have used AeroPace Therapy in two clinical studies, and also during the pandemic under EUA, to help wean ventilator dependent patients at our institution. The AeroPace System provides a novel and exciting treatment therapy for an underserved patient population with no other options today.”
As the FDA reviews the AeroPace System, its approval could signify a breakthrough in the treatment of patients who are dependent on mechanical ventilation, offering them a path to independence and improved quality of life.
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