Liberate Medical announced today that it received FDA emergency use authorization (EUA) for its VentFree respiratory muscle stimulator.
Crestwood, Ky.-based Liberate’s VentFree system is designed to reduce disuse atrophy of the abdominal wall muscles, which could reduce the number of days that adult patients require mechanical ventilation. It could also be used for patients with COVID-19, which, by reducing the time spent on ventilators, could limit infections and increase ventilator availability during the pandemic.
According to a news release, VentFree uses proprietary non-invasive neuromuscular electrical stimulation to contract the abdominal wall muscles in synchrony with exhalation during mechanical ventilation. This enables treatment to begin from the early phase of mechanical ventilation until the patient is weaned from it.
VentFree won FDA breakthrough device designation and CE Mark approval last year and recently completed two clinical trials confirming that, compared to placebo stimulation, the device may reduce ventilation duration and length of stay in the intensive care unit.
“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,” Liberate co-founder & CEO Angus McLachlan said in the release.
Liberate noted that it is working with manufacturers in Minnesota, Ohio and Iowa to ramp up production and distribution. The company expects VentFree devices to be made available to ICUs around the country immediately.