FDA grants breakthrough status to Liberate's ventilator device
FDA has awarded breakthrough device designation to Liberate Medical’s technology designed to cut the duration of mechanical ventilation.
The non-invasive electrical stimulation device is designed to counter the respiratory muscle weakness that can occur during prolonged periods of mechanical ventilation, thereby helping to wean patients off life support systems and reduce morbidity.
Liberate Medical, which has generated pilot data on the VentFree device, will now have the chance to get more frequent input from FDA as it develops the technology.
Prolonged periods of ventilator support present problems for patients and healthcare systems. As the number of days a patient is on ventilator support increases, the risk of serious complications such as pneumonia and muscle atrophy increases. Risk of death correlates with the duration of time spent on ventilator support.
According to figures shared by Liberate Medical, hospital mortality almost doubles among patients on ventilator support for a week or more. Around two-fifths of ventilated patients are on the support systems for more than four days. Long-term outcomes are worse in this group of patients, too.
The data partly reflect the fact that people who need to spend a week or more on ventilator support systems are likely to be very ill. However, the ventilator itself contributes to the problem by leading to respiratory muscle weakness, making it harder for patients to come off mechanical support and make a fast, full recovery when they do.
Liberate Medical thinks electrical muscle stimulation can help these patients. VentFree is designed to stimulate expiratory muscles when the patient is exhaling. In doing so, the device may counter the respiratory muscle weakness associated with mechanical ventilation.
To date, Liberate Medical has only generated pilot data on VentFree, which it will present in May. But it is already talking up the prospects of the device chipping away at the $20 billion sum prolonged periods of ventilator support are estimated to cost the U.S. healthcare system.
“Our pilot trial ... 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,” Liberate Medical CEO Angus McLachlan said in a statement.
The breakthrough device designation could help Liberate Medical accelerate the process of finding out if VentFree can live up to McLachlan’s expectations. As one of a little more than 100 devices to receive the breakthrough designation, VentFree will benefit from priority review and extra support from FDA, which offers participants in the program advice on clinical and technical development.