The US FDA has granted a Breakthrough Device Designation for Liberate Medical’s VentFree muscle stimulator. The device is designed to prevent muscle atrophy and reduce the number of days of ventilator support in adults who require mechanical ventilation.

Approximately 40% of mechanically ventilated patients require more than four days of ventilator support, and the number of these patients is increasing at 5.5% per year, according to the company.

Prolonged periods of mechanical ventilation can cause life-threatening complications including barotrauma, ventilator associated pneumonia, muscle atrophy and psychological conditions. Invasive mechanical ventilation commonly results in respiratory muscle weakness, which is a major underlying factor for patients requiring prolonged periods of ventilator support. Current methods of respiratory muscle training cannot be used when patients are sedated or delirious, as is common during mechanically ventilation in the ICU.

The VentFree muscle stimulator uses proprietary noninvasive electrical muscle stimulation technology to activate the expiratory muscles in synchrony with exhalation. This non-invasive approach, which does not rely on patient interaction and can be used throughout the process of mechanical ventilation, may provide a novel solution to prevent respiratory muscle atrophy. In turn, this may allow patients to be weaned from mechanical ventilation sooner than would otherwise be possible.

“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. “Patients requiring prolonged periods of ventilator support suffer from significant rates of mortality and clinical complications, both while in the hospital and after discharge, and cost the US healthcare system about $20B 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. In doing so, we believe that it has the potential to save lives, reduce morbidity and significantly reduce hospital costs.”

The VentFree muscle stimulator is an investigational device only and is not for sale in any country.