The Subsalve Oxygen Treatment Hood is approved for emergency use (EUA) during the Covid-19 pandemic.

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Subsalve Oxygen Treatment Hood 

Use Protocols & Setup

Resources & FAQs

View this Resource & FAQ page for training, current research, use protocols, and device FAQs.

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The Subsalve Oxygen Treatment Hood is the critical patient interface to enable Hooded/Helmet Positive Airway Pressure (HPAP) ventilation techniques, and was developed in response to the Covid-19 pandemic.

HPAP is also referred to as non-invasive positive pressure ventilation (NIPPV), helmet NIV, helmet CPAP, or simply helmet based ventilation.

HPAP ventilation techniques allow clinicians to:

  • increase patient airway pressure from 3 to 20 cm H2O
  • elevate FiO2 to therapeutic levels
  • reduce viral exposure for healthcare workers

The Subsalve Oxygen Treatment Hood is the only such US manufactured device with FDA Emergency Use Authorization (EUA) for respiratory distress and is being distributed within the US and internationally.

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  • Among patients with ARDS, treatment with helmet [hood] NIV resulted in a significant reduction of intubation rates.

    Patel et al. , JAMA. 2016;315(22):2435u20132441

  • …the helmets that your company [Subsalve] produces are fantastic and already saved and continue saving lives in Bolivia. Our physicians are more familiar and eager to use the device and share the benefits with other hospitals.

    Dr. Cesar Vargas, los Medicos Bolivianos online

  • Approximately thirty to fifty percent of patients were successfully managed with helmet respiratory support, not requiring escalation to intubation and mechanical ventilation.

    Armirfarzan et al., Ther Adv Respir Dis 2020, Vol. 14: 1u20133

Urgent Humanitarian Aid Relief is Underway

A portion of proceeds from all purchased devices and systems is donated to Ocean Opportunity Inc., a Rhode Island based
501(c)3 not for profit organization. OO is committed to furthering related education, research, and facilitating aid relief during the pandemic. Consider a tax-deductible donation today to expand our reach.

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The project has been supported by multiple partners, and has resulted in the provision of humanitarian aid to numerous countries including Bolivia, Honduras, Guatemala, Nicaragua, Mexico, Haiti, Nigeria, Indonesia, Iraq, and others.

Covid-19 Response Partners

  • Subsalve Oxygen Treatment Hood

Regulatory Notice

Effective August 4th, 2020, the US FDA has authorized the Subsalve Oxygen Treatment Hood for emergency use in healthcare settings to treat patients during the COVID-19 pandemic, and has been added to Appendix B of the FDAu2019s Emergency Use Authorization (EUA).

The Subsalve Oxygen Treatment Hood is a patient interface intended for helmet based Non Invasive Positive Pressure Ventilation (NIPPV) according to clinician established protocols.

  • This device has not been FDA cleared or approved
  • This device has been authorized by FDA under an EUA
  • This device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of ventilators, ventilator tubing connectors, and ventilator accessories under section 564(b)(1) of the Act, 21 U.S.C. u00a7 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
  • Fact Sheet forHealthcare Providers
  • Fact Sheet forPatients