Liberate Medical announced that it has received FDA Emergency Use Authorization for its VentFree™ Respiratory Muscle Stimulator, intended to be used to reduce disuse atrophy of the abdominal wall muscles, which may reduce the number of days adult patients require mechanical ventilation, including those patients with COVID-19.
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. Fewer days on ventilation may also increase the availability of ventilators during the COVID-19 pandemic.
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. Last year VentFree™ received FDA Breakthrough Device Designation and CE marking in the European Union.
“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.
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 stimulator 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.
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.
About Emergency Use Authorization of VentFree
VentFree has neither been cleared or approved for the indication for use by health care providers to treat adult patients by reducing disuse atrophy of the abdominal wall muscles, which may reduce the number of days of ventilator support in patients who require mechanical ventilation in healthcare settings during the COVID-19 pandemic.
VentFree has been authorized for the above emergency use by FDA under an Emergency Use Authorization. VentFree has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About Liberate Medical
Liberate Medical is a clinical / commercial stage medical device company that develops neuromuscular electrical stimulation technology to improve the quality and reduce the cost of care for patients with pulmonary disorders.