Lungpacer Medical has secured emergency use authorisation (EUA) from the US Food and Drug Administration for its novel Diaphragmatic Pacing Therapy System (DPTS) to immediately treat in patients on invasive mechanical ventilators at high risk of weaning failure, including COVID-19 patients.
Lungpacer DPTS is claimed to be the first minimally invasive, temporary and transvenous phrenic-stimulation system approved under FDA EUA status.
The non-surgical, non-implanted and diaphragm stimulation therapy is offered via central venous catheter
The non-surgical, non-implanted and diaphragm stimulation therapy is provided through a central venous catheter (CVC), similar to central lines currently placed in mechanically ventilated ICU patients.
The unique central line is applied to deliver both fluids and medications, as well as help to integrate the capability to activate the diaphragm muscle through transvenous phrenic-nerve stimulation.
The simulation will help strengthen a weakened diaphragm or ventilator induced diaphragm disfunction (VIDD), already atrophied by mechanical ventilation. It is expected to help patients wean off the ventilator more quickly.
Lungpacer Medical CEO Doug Evans said: “The COVID-19 pandemic, also known as SARS-COVID-2, has stimulated tremendous innovation to improve outcomes for these patients.
“I am very proud of the Lungpacer team who have worked diligently to make this therapy available in a very short period of time, and I want to thank the FDA for their timely review and support.
“We are excited for the opportunity to provide healthcare professionals with access to the Lungpacer therapy to help their critically ill patients.”
Headquartered in Vancouver, Canada, Lungpacer Medical is engaged in offering temporary, non-surgical, minimally invasive technologies to make mechanical ventilation more effective and safer. In 2016, the company’s Lungpacer DPTS secured a Breakthrough Designation from the FDA.
In May 2016, Lungpacer Medical secured expedited access pathway (EAP) status from the FDA or its diaphragm pacing system to treat patients who have been unable to wean from mechanical ventilation.
