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

Share Article

Rhode Island companies receive first FDA approval for helmet ventilation as alternative solution to intubation

Bolivian patient received helmet ventilation treatment with Subsalve Oxygen Treatment Hood. Photo courtesy Dr. Cesar Vargas.

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.

Subsalve USA is a 40 year manufacturer of high performance engineered inflatables focusing on underwater, defense, and other markets. Subsalve teamed up with Lombardi Undersea LLC, a diving technology research company specializing in life systems integration, to further research and market the device.

The Subsalve Oxygen Treatment Hood now stands alone as the only US manufactured hooded ventilator that is authorized for respiratory distress from Covid-19. More than 20,000 hoods have been distributed internationally in only a few short months since project inception. Positive results are coming in from resource limited areas including Bolivia, Nicaragua, Guatemala, Nigeria, and multiple other countries.

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Michael R Lombardi
Visit website