The US Food and Drug Administration (FDA) has issued Emergency Use Authorisation (EAU) for Subsalve’s oxygen treatment hood, in order to help those suffering from coronavirus.
Subsalve’s oxygen hood is a one-piece, soft, single patient use device used for helmet/hooded non-invasive positive pressure ventilation. The ventilation technique has been used in Italy for decades but is a new treatment for North America.
Until the issued EUA, only off-label use of helmet ventilation had been implemented for treating respiratory distress.
During the pandemic, mortality once intubated has been reported to be as high at 80% in the US. However, with the newly available oxygen treatment hood, physicians can proactively treat early respiratory distress and hypoxemia without incubation.
The Subsalve oxygen treatment hood now stands alone as the only US manufactured hooded ventilator that is authorised for respiratory distress from coronavirus.
More than 20,000 hoods have been distributed internationally in only a few months.