Canada-based medical device company Lungpacer Medical has secured expedited access pathway (EAP) designation from the US Food and Drug Administration (FDA) for its diaphragm pacing system (DPS) to treat patients.
The EAP is a new FDA programme intended to allow increased access for patients to evolving technologies.
Lungpacer’s DPS was granted the EAP status because the technology aims at treating and diagnosing terminal or irreversibly debilitating diseases or conditions and subsequently caters to an unmet medical need.
Lungpacer president and CEO Doug Evans said: “This FDA action will enable our team to communicate more efficiently with the FDA to ensure the most rapid path to commercialisation 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.”
The new technology is said to cater to patients who have been unable to wean from mechanical ventilation (MV).
While MV can be life-saving for many critically ill patients it can also be harmful to the patient as continued MV and sedation hamper the normal activation of the diaphragm muscle, which then atrophies rapidly, known as ventilator induced diaphragm dysfunction (VIDD).
Additionally, positive-pressure invasive ventilation can damage the lungs (ventilator induced lung injury, (VILI)) and is associated with ventilator-associated pneumonia (VAP).
Lungpacer’s DPS is designed to activate the diaphragm using a temporary, minimally invasive, transvascular nerve stimulation approach.
It involves an intravenous insertion of Lungpacer electrodes which rhythmically activates the diaphragm and prevents potential diaphragm muscle-disuse atrophy in a patient who fails to wean and becomes ventilator-dependent.
The DPS can also restore negative pressure ventilation, providing a physiological respiratory pattern and eliminating the levels of positive pressure ventilation and its harmful effects on the lungs.
It is said to facilitate a faster patient recovery, reducing the hospitalisation cost incurred by patients and subsequently improving the health outcomes.
Image: A mechanically ventilated patient on an Intensive Care Unit. Photo: courtesy of Rcp.basheer.