EXTON, PA — Lungpacer Medical announced that its AeroPace® System has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA). The approval marks a pivotal moment in respiratory care, offering a first-of-its-kind solution for patients on prolonged mechanical ventilation.
The AeroPace System uses neurostimulation through an electrode-equipped cardiovascular catheter and software to engage and strengthen the diaphragm. It is specifically designed for adults who have been mechanically ventilated for 96 hours or more and have not been successfully weaned. The system aims to improve weaning success, shorten ventilation time, and reduce the need for reintubation.
Clinical studies demonstrate significant benefits with the AeroPace System. It reduces the risk of long-term mechanical ventilation at 30 days by up to 37%, while speeding up the weaning process by nearly three days. The system also lowers the risk of reintubation within 30 days by up to 60%.
“Today’s approval of our AeroPace System, an FDA designated Breakthrough Device, is transformative for respiratory care and represents a new era in which clinicians will now have a treatment option for critical care patients who have failed to wean from mechanical ventilation,” said Doug Evans, Chief Executive Officer of Lungpacer Medical.
Evans emphasized the device’s potential to revolutionize treatment for critically ill patients. “We expect that the AeroPace System will improve the standard of care and transform the future care of mechanically ventilated patients by helping them recover durable independent breathing. In memory of my son, Cameron, who endured the challenges of mechanical ventilation, we are all grateful to the dedicated physicians who conducted our three clinical trials and to the brave patients who participated in them such that their efforts will help many more patients to wean more quickly.”
The FDA approval for the AeroPace System adds a critical tool for clinicians in managing and improving outcomes for mechanically ventilated patients, setting a new standard in respiratory care.
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