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.