News from the FDA/CDC

FDA grants EUA to muscle stimulator to reduce mechanical ventilator usage


 

The Food and Drug Administration has issued an Emergency Use Authorization (EUA) for the VentFree Respiratory Muscle Stimulator in order to potentially reduce the number of days adult patients, including those with COVID-19, require mechanical ventilation, according to a press release from Liberate Medical.

FDA icon Wikimedia Commons/FitzColinGerald/ Creative Commons License

In comparison with mechanical ventilation, which is invasive and commonly weakens the breathing muscles, the VentFree system uses noninvasive neuromuscular electrical stimulation to contract the abdominal wall muscles in synchrony with exhalation during mechanical ventilation, according to the press release. This allows patients to begin treatment during the early stages of ventilation while they are sedated and to continue until they are weaned off of ventilation.

A pair of pilot randomized, controlled studies, completed in Europe and Australia, showed that VentFree helped to reduce ventilation duration and ICU length of stay, compared with placebo stimulation. The FDA granted VentFree Breakthrough Device status in 2019.

“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,” Angus McLachlan PhD, cofounder and CEO of Liberate Medical, said in the press release.

VentFree has been authorized for use only for the duration of the current COVID-19 emergency, as it has not yet been approved or cleared for usage by primary care providers.

Recommended Reading

COVID-19: To have and to hold ... in quarantine
MDedge Dermatology
COVID-19: Social distancing with young children
MDedge Dermatology
Hydroxychloroquine-triggered QTc-interval prolongations mount in COVID-19 patients
MDedge Dermatology
FDA tightens requirements for COVID-19 antibody tests
MDedge Dermatology
Cancer screening, monitoring down during pandemic
MDedge Dermatology
Case reports illustrate heterogeneity of skin manifestations in COVID patients
MDedge Dermatology
Doctor with a mask: Enhancing communication and empathy
MDedge Dermatology
Teledermatology Fast Facts
MDedge Dermatology
Fountains of Wayne, and a hospitalist’s first day, remembered
MDedge Dermatology
COVID-19 death rate was twice as high in cancer patients in NYC study
MDedge Dermatology