STIMULATE TO LIBERATE
Preparing to wean from day one of mechanical ventilation
How it Works
VentFree contracts the expiratory muscles during mechanical ventilation to keep them active.
In doing so, it may reduce atrophy and may reduce the duration of mechanical ventilation.
An Unmet Need in Mechanically Ventilated Patients
Expiratory muscles play an important role in respiration, especially in patients with impending respiratory failure.*
Although mechanical ventilation provides life sustaining respiration, prolonged use is associated with negative side effects, including respiratory muscle atrophy.
Expiratory muscle atrophy is found in mechanically ventilated patients and is associated with weaning failure and delayed extubation.*
Patients who require more than four days of mechanical ventilation suffer from high rates of hospital mortality, morbidity and post-discharge complications.*
*Shii, Z-H, et al. Intensive Care Med 2019
Preparing to Wean from Day One of Ventilation
The VentFree Respiratory Muscle Stimulator uses proprietary non-invasive neuromuscular electrical stimulation to contract the abdominal wall muscles in synchrony with exhalation during mechanical ventilation.
As electrical stimulation does not require patient cooperation, therapy can begin from day one of mechanical ventilation while patients are sedated or delirious.
This breakthrough approach, which is quick and simple to use, is intended to reduce abdominal muscle atrophy, which may reduce the time taken to liberate patients from mechanical ventilation.
VentFree respiratory muscle stimulator contracts respiratory muscles in mechanically ventilated patients using non-invasive electrical stimulation synchronized with exhalation.
Improving Clinical Outcomes
A pilot randomized controlled trial found that mechanical ventilation duration and ICU length of stay were shorter in patients who received stimulation with VentFree muscle stimulator compared to those who received placebo.*
Reduced days on mechanical ventilation can potentially lead to reduced morbidity and mortality, improved quality of life and significant savings for the health care provider.*
Regulatory Information
The VentFree Respiratory Muscle Stimulator is CE marked and available for sale inside the European Economic Area.
The VentFree Respiratory Muscle Stimulator has emergency use authorization in the USA 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.
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. ยง 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
To report an adverse event, please call: 1-800-683-5526