A pilot study of Liberate Medical’s VentFree Muscle Stimulator demonstrated the feasibility of the device to treat mechanically-ventilated critical care patients, according to data presented at ATS 2019 by the company.
The VentFree Muscle Stimulator, which received Breakthrough Device Designation from the FDA in January 2019, is an electrotherapy device that applies stimulation to the abdominal wall muscles in synchrony with mechanical ventilation. Liberate Medical reports the device is designed to prevent abdominal muscle atrophy and reduce the time to wean patients from mechanical ventilation.
The pilot study was assessor blinded, randomized, sham-controlled, and included 20 participants. Results found the device may be able to reduce the duration of ventilator support in critically ill patients requiring prolonged mechanical ventilation, with no device-related serious adverse events reported.
The study principal investigator, Euan McCaughey, PhD, 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 US healthcare 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.”