gammaCore Sapphire™ CV (non-invasive vagus nerve stimulator)

For the Acute Treatment of Asthma Exacerbation in Known or Suspected COVID-19 Patients

Fact Sheet for Healthcare Providers
Fact Sheet for Patients
Instructions for Use

gammCore Sapphire™ CV has neither been cleared nor approved for acute use at home or in a healthcare setting 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, by using non-invasive Vagus nerve Stimulation (nVNS) on either side of the patient’s neck during the Coronavirus Disease 2019 pandemic.

gammCore Sapphire™ CV has been authorized for the above emergency use by FDA under an Emergency Use Authorization.

gammCore Sapphire™ CV has been authorized only for the duration of hte delcalation that circumstances exist justifying the authorization of the emergency use of medical devices under sction 564(b)(1) of the Act, 21 U.S.C $ 360bbb-3(b)(1), unless the authorization is terminated or revoked.