CRESTWOOD, KY, 21st October 2019 – Liberate Medical, a medical device company developing novel non-invasive electrical muscle stimulation devices to help patients with pulmonary conditions, today announced that it has received CE marking for its VentFree™ Respiratory Muscle Stimulator and ISO 13485 certification for its quality management system.
The VentFree stimulator applies proprietary non-invasive electrical stimulation to the abdominal muscles during exhalation. VentFree is intended to prevent abdominal muscle atrophy and reduce ventilation duration in mechanically ventilated patients.
Liberate published the results of its pilot trial of VentFree in July, which found a shorter ventilation duration and ICU length of stay in patients who received VentFree compared with standard of care.
The VentFree stimulator received Breakthrough Device Designation from the FDA in January. CE Marking indicates that a medical device meets all safety and performance standards required by the European Union.
Angus McLachlan, Liberate Medical’s co-founder and CEO said, “We are delighted to have reached this milestone. We believe that the VentFree stimulator has the potential to meaningfully improve clinical outcomes in patients receiving mechanical ventilation. We look forward to engaging key opinion leader medical professionals throughout Europe for the introduction of this breakthrough technology.”
About Liberate Medical
Liberate Medical is a medical device company that develops neuromuscular electrical stimulation technology to improve the quality and reduce the cost of care for patients with pulmonary disorders. For more information please visit https://liberatemedical.com.
About the VentFree Respiratory Muscle Stimulator
Invasive mechanical ventilation commonly weakens the breathing muscles, increasing the need for further ventilator support. The VentFree respiratory muscle stimulator activates the abdominal muscles in mechanically ventilated patients using proprietary non-invasive electrical stimulation applied during exhalation. As electrical stimulation does not require patient participation, therapy can begin from day one of mechanical ventilation while patients are sedated or delirious. This breakthrough therapy, which is quick and simple to use, is intended to prevent abdominal muscle atrophy and reduce the time taken to liberate patients from mechanical ventilation.
Reduced days on mechanical ventilation can potentially lead to reduced morbidity and mortality, improved quality of life and considerable savings for the health care provider.
Outside of the European Union, the VentFree respiratory muscle stimulator is an investigational device only and is not for sale.