FDA Issues Emergency Use Authorization for gammaCore Sapphire CV Device

Jul 14, 2020 | COVID-19

On July 10, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the gammaCore Sapphire CV (electroCore Inc.) 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.

The gammaCore Sapphire CV is a multiuse, handheld, rechargeable, portable, non-invasive vagus nerve stimulator that produces a low-voltage electrical signal, which is transmitted through the skin of the neck to the vagus nerve. The user applies the device over the vagus nerve by holding the stimulation surfaces against the skin of the side of the neck, maintaining an uninterrupted conductive path from the stimulation surfaces to the skin with the use of the provided conductive gel. The device may be operated by a healthcare provider or by the patient (self-treatment).

The gammaCore Sapphire CV may help patients with reduced airflow and dyspnea due to exacerbation of asthma from COVID-19 by potentially inhibiting airway constriction, resulting in smooth muscle relaxation and reducing the potential for the virus to induce such symptoms. Stimulation from the gammaCore Sapphire CV can be used on either side of the patient’s neck. Each self-administered treatment should consist of two consecutive 2-minute stimulations (up to 24 stimulations in a 24-hour period) at the onset of respiratory distress or shortness of breath.

To date, there are no FDA approved or cleared devices for this intended use. As such, the FDA has issued numerous EUAs to address the diagnosis and treatment of COVID-19, as well as to meet the needs of health care providers for appropriate personal protective equipment (PPE). The EUA authority allows the FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear threats by facilitating the availability and use of medical countermeasures needed during public health emergencies. Early reports of COVID-19 infections demonstrate a high level of aggressive, prolonged inflammation in the airways which will likely result in significant worsening of asthma symptoms in the large asthmatic population. While there are drug treatments available, the gammaCore Sapphire CV may provide benefits to some patients for whom standard drug therapy is unable to meet their needs. The FDA has also determined that the available information also indicates that the gammaCore Sapphire CV may be an effective alternative for those who cannot tolerate beta agonists or for those whose exacerbations cannot be controlled with the limited use associated with standard inhaled treatments.

The gammaCore Sapphire CV is not intended for use:

  • in patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device;

  • if the patient has a metallic device, such as a stent, bone plate, or bone screw, implanted at or near their neck;

  • if the patient has an open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on their neck at the treatment location.

A Hayes Health Technology Assessment on the use of the gammaCore device for prevention or treatment of cluster headache is available here.

Food and Drug Administration (FDA). Emergency Use Authorization for gammaCore Sapphire CV. Issued July 10, 2020. Available at: click here. Accessed July 14, 2020.

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