The US Food and Drug Administration (FDA) has awarded Breakthrough Therapy Designation to the VentFree muscle stimulator. The device is being developed to prevent atrophy in breathing muscles and reduce the number of days of ventilator support in adult patients who need mechanical ventilation.
“Breakthrough Device Designation is important recognition of the potential for the VentFree muscle stimulator to address a serious unmet medical need and will help us bring the device to patients as efficiently as possible,” said Angus McLachlan, PhD, CEO and co-Founder of Liberate Medical, in a statement.
McLachlan added that patients who need ventilator support for long periods of time have high rates of mortality and many clinical complications, costing the US health care system about $20 billion per year.
“Our pilot trial, which has been selected for oral presentation at the ATS International Conference in May, provided an initial indication that the VentFree muscle stimulator may be able reduce the duration of ventilator support in these patients,” said McLachlan. “In doing so, we believe that it has the potential to save lives, reduce morbidity and significantly reduce hospital costs.”
The sham-controlled VentFree pilot trial included 20 participants who were randomized to receive neuromuscular electrical stimulation to the abdominal wall muscles or sham stimulation. The active stimulation or sham stimulation was applied via VentFree prototype 2 times per day for 30 minutes, 5 days per week, for 6 weeks or until the patient was weaned from mechanical ventilation.
The active neuromuscular electrical stimulation was applied at a frequency of 30 Hz, a pulse width of 352us and a maximum intensity of 100mA. The sham treatment was applied with a frequency of 10 Hz, a pulse width of 352us, and an intensity of 15 mA.
The primary outcome was the thickness of abdominal wall muscles, while secondary measures included the thickness of the diaphragm and thickness of the rectus abdominis muscle over the study timeframe, and maximum expiratory pressure and maximum inspiratory pressure within 24 hours after extubation.
At the time of publication, no study results were available.