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FDA authorizes Subsalve Oxygen Treatment Hood for emergency use to treat Covid-19

The US Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the Subsalve Oxygen Treatment Hood (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-august-6-2020).

The Subsalve hood is a one-piece, soft, single patient use device used for helmet/hooded non-invasive positive pressure ventilation. This ventilation technique has been used in Italy for decades to treat respiratory distress, but is very new in the United States. Until this EUA issued, only off-label use of helmet ventilation has been implemented for treating respiratory distress. A 2016 clinical trial from the University of Chicago showed significant reductions in required invasive intubations. Widespread adoption has been slow given this off-label regulatory challenge.

During Covid-19, mortality once intubated has been reported to be as high as 80% in the US. With the newly available Subsalve Oxygen Treatment Hood, physicians can proactively treat early respiratory distress and hypoxemia without intubation. The very nature of helmet ventilation also filters the patient’s exhalations to mitigate viral exposure to healthcare workers.

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