ABSTRACT

Fact Sheet for Healthcare Providers: Emergency Use of GammaCore Sapphire CV During the COVID-19 Pandemic   [open pdf - 153KB]

From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the gammaCore Sapphire CV during the Coronavirus Disease 2019 (COVID-19) pandemic. Early reports of COVID-19 infections demonstrate a high level of aggressive, prolonged inflammation in the airways which may result in significant worsening of asthma-related symptoms in the large adult asthmatic population. The gammaCore Sapphire CV is intended for acute use at home or in healthcare settings to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, using noninvasive vagus nerve stimulation (VNS) on either side of the patient's neck during the (COVID-19) pandemic."

Publisher:
Date:
2020-07-10
Series:
Copyright:
Public Domain
Retrieved From:
U.S. Food and Drug Administration: https://www.fda.gov/
Format:
pdf
Media Type:
application/pdf
URL:
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