Portable Vagus Nerve Stimulator Cleared for Emergency Use During Coronavirus Pandemic

The U.S. Food and Drug Administration has allowed the emergency use of a non-invasive Vagus nerve stimulator in treating COVID-19 patients. The handheld device designed by electroCore works by sending a train of electric pulses through the skin to a nerve in the neck. The pulse train causes the airways in the lungs to open, and it may also have an anti-inflammatory effect.

How to use the device

The gamma Core Sapphire CV device can be used both in clinics, hospitals, and at home. They can be used in treating adults with suspected or known cases of COVID-19. Adults should be showing increasing asthma-related symptoms, reduced airflow, and those whose drug therapies are not tolerated or provide insufficient symptom relief.

The Vagus nerves are found on either side of the neck, and they connect structures deep in the brain with the body’s internal organs. The medical device manufacturers have been utilizing this brain-organ highway in treating postpartum bleeding, epilepsy, and depression. ElectroCore’s device has also further been approved for treating both acute and long-term cluster headaches and migraines.

However, the company found itself in the thick of research into the Vagus nerve stimulation effect on airways accidentally. It was noticed when a patient was asked what if they had other experiences. One patient recalled, and the experience was that it’s the headache that went away. Henceforth, the company primarily focused on the headache. The company also performed some stimuli used in headache and migraine relief to the lungs, which worked well.

How the device is used in treating COVID-19

The device appeared to have a two-prolonged effect concerning the lungs in treating COVID-19. First is opening up the end terminals of the lung’s airways. The airways are therefore mediated by the signals going up to the nerve into the brain. The second mode is the separate anti-inflammatory effect caused by the signal moving down the nerve into the body. The second signal system also has some impact on the production of cytokines.

Cytokines are a bigger class of small proteins that cells use in signaling each other, some of which play a role in inflammation. Overproduction of cytokines can lead to a condition known as cytokine storm syndrome, which has been observed in some COVID-19 patients. It always happens when the immune system response spins out of control and can shut down the lungs and other organs.

However, under the FDA authorization, the device has only been approved for use in the COVID-19 national emergency. Researchers are still performing some clinical trials, and the FDA has invited companies to seek permanent approval of the device.

Such emergency use approval is good news to biomedical companies like LexaGene Holdings Inc. (TSXV: LXG) (OTCQB: LXXGF) since they are assured that in exceptional circumstances, their innovations will get expedited regulatory approval.

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