Canada-based medical device company Lungpacer Medical has received the US Food and Drug Administration (FDA) premarket approval (PMA) for its AeroPace System.
The AeroPace System is indicated to improve weaning success, increase weaning, decrease ventilator days, and reduce reintubation, in adult patients on mechanical ventilation.
The system leverages neurostimulation through an electrode containing a cardiovascular catheter and a software-controlled system to contract and strengthen the diaphragm.
It is contraindicated in patients with active implanted cardiac pacemakers, defibrillators, or other implantable electronics within proximity to the device.
Lungpacer Medical CEO Doug Evans said: “Today’s approval of our AeroPace System 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.
“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 clinicals trials and to the brave patients who participated in them such that their efforts will help many more patients to wean more quickly.”
Lungpacer develops advanced interventional therapies to free patients from mechanical ventilation (MV) and improve diaphragm, lung, heart, and brain health.
The company said its AeroPace System is designed to strengthen the diaphragm, advance recovery and weaning from ventilator dependence.
The system provides patients with several clinical advantages compared with the current standard of care, including more patients weaned, and faster weaning by nearly 3 days.
It reduces the patient’s risk of remaining on mechanical ventilation by up to 37% at 30 days and reduces the risk of reintubation at 30 days by up to 60%, said the company.
University of Toronto medicine and physiology associate professor Ewan Goligher said: “The majority of patients requiring mechanical ventilation develop significant diaphragm muscle weakness.
“This seriously impairs their ability to recover spontaneous breathing which is known to be associated with poor clinical outcomes.
“These data indicate that Lungpacer diaphragm pacing technology can accelerate recovery for patients who have difficulty weaning from mechanical ventilation.”
