Lungpacer Medical has secured expedited access pathway (EAP) status from the US Food and Drug Administration (FDA) for its diaphragm pacing system (DPS) to treat patients who have been unable to wean from mechanical ventilation (MV).
Lungpacer DPS is a breakthrough technology that will be used to treat patients, who struggle to breathe independently.
The Lungpacer system will activate the diaphragm using a temporary, minimally invasive and transvascular nerve stimulation approach.
It is expected to restore diaphragm strength and endurance in patients who have failed to wean from MV after their diaphragm muscle atrophied as a consequence of ventilator induced diaphragm dysfunction (VIDD).
Lungpacer Medical president and CEO Doug Evans said: "Our team is thrilled that the Lungpacer DPS was granted EAP status. This FDA action will enable our team to communicate more efficiently with the FDA to ensure the most rapid path to commercialization in order to help our patients.
"Mechanically ventilated patients can struggle with regaining the ability to breathe independently following extended illness, and we look forward to helping these individuals regain the ability to breathe independently faster."
MV can be life-saving for most of the critically ill patients, but sometimes it is also harmful to the patients, as continued MV and sedation interrupt the normal activation of the diaphragm muscle, which then atrophies rapidly and profoundly (VIDD).
The positive-pressure invasive ventilation may damage the lungs (ventilator induced lung injury, (VILI)). It is also associated with ventilator-associated Pneumonia (VAP).
According to the company, VIDD, VILI and VAP are key contributing factors to the frequent difficulty in weaning patients from the ventilator.
Image: X-ray of chest, showing top of diaphragm. Photo: courtesy of Chikumaya and Mikael Häggström.