Liberate Medical, a clinical-stage medical device company, developing novel electrical muscle stimulation devices that non-invasively address pulmonary conditions, announced the results from its recently completed pilot trial of the VentFree Muscle Stimulator during an oral presentation at the American Thoracic Society International Conference in Dallas, TX.
The VentFree Muscle Stimulator, which received Breakthrough Device Designation from the FDA in January, is an electrotherapy device that applies stimulation to the abdominal wall muscles in synchrony with mechanical ventilation. It’s designed to prevent abdominal muscle atrophy and reduce the time to wean patients from mechanical ventilation.
The pilot trial, conducted in collaboration with Neuroscience Research Australia at the Prince of Wales Hospital, Sydney Australia was assessor-blinded, randomized, sham-controlled and included twenty participants. The study demonstrated the feasibility of using the VentFree Muscle Stimulator with mechanically ventilated critically ill patients. No device-related serious adverse events were reported and the results indicated that that the device may be able to reduce the duration of ventilator support in critically ill patients requiring prolonged mechanical ventilation. The abstract is available online at the American Thoracic Society website (https://www.abstractsonline.com/pp8/#!/5789/presentation/25886).
The study principal investigator, Dr. Euan McCaughey, Ph.D. commented: “We believe the results of this trial are highly encouraging and that the VentFree muscle stimulator by Liberate Medical has the potential to meaningfully improve clinical outcomes in these patients. We greatly look forward to the next phase of clinical studies.”
“Patients requiring prolonged mechanical ventilation have significant rates of illness and death, both while in the hospital and after discharge, and cost the U.S. health care system about $20B per year,” said Angus McLachlan, PhD, CEO and co-Founder of Liberate Medical. “The results from this successful pilot study support our belief that VentFree has the potential to save lives, reduce morbidity and significantly decrease hospital costs for these patients.”
Source: Liberate Medical