Liberate Medical has received an FDA emergency use authorization for the VentFree Respiratory Muscle Stimulator, which applies neuromuscular electrical stimulation to the abdominal wall muscles during invasive ventilation.

VentFree received FDA Breakthrough Device Designation and CE marking in the European Union in 2019.

Studies have shown the technology reduced the number of days adult patients required mechanical ventilation. Reducing the time patients spend on mechanical ventilation may reduce the risks of prolonged mechanical ventilation, which include hospital acquired infections, deteriorated quality of life and death, according to Liberate Medical. Fewer days on ventilation may also increase the availability of ventilators during the COVID-19 pandemic, the company said.

Two pilot randomized controlled trials, recently completed in Europe and Australia, indicated that compared with placebo stimulation, the VentFree may reduce ventilation duration and ICU length of stay.

Invasive mechanical ventilation commonly weakens the breathing muscles, increasing the need for further ventilator support. Current methods of respiratory muscle training cannot be used when patients are sedated or delirious, which is common among critically ill patients. The VentFree uses proprietary non-invasive neuromuscular electrical stimulation to contract the abdominal wall muscles in synchrony with exhalation during mechanical ventilation. These features enable treatment to begin from the early phase of mechanical ventilation, while patients are sedated or delirious, and continue until the patient is successfully weaned from mechanical ventilation.

“We are grateful to the FDA for recognizing the potential of VentFree and feel privileged to have the opportunity to help patients on mechanical ventilation during the COVID-19 pandemic,” said Angus McLachlan PhD, co-founder and CEO of Liberate Medical. 

Liberate Medical has been working with manufacturers in Minnesota, Ohio and Iowa to speed up production and distribution and expects VentFree™ devices to be immediately available to hospital ICUs nationwide.