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

gammaCore Sapphireᵀᴹ 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 (COVID-19) pandemic.

gammaCore Sapphireᵀᴹ CV has been authorized for the above emergency use by FDA under an Emergency Use Authorization.

gammaCore Sapphireᵀᴹ CV has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked.

The gammaCore Sapphireᵀᴹ CV is contraindicated for:

• Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Patients with a metallic device, such as a stent, bone plate, or bone screw, implanted at or near your neck
• Patients with an open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on their neck at the treatment location

Patients should not use the gammaCore Sapphireᵀᴹ CV:

• While they are driving, operating machinery, or during any activity that may put the patient at risk of injury
• If they have any planned surgeries that may involve implants. The Patient should advise their HCP accordingly
• Near microwave machines, magnetic resonance imaging, radio frequency surgical, or computer-aided tomography machine
• In an explosive atmosphere or in the presence of flammable gas mixtures
• If the patient has wet skin, is in water, or just stepped out of the water (e.g. shower, bath, pool)
• If the patient is using another device at the same time (e.g. TENS Unit, muscle stimulator) or any portable electronic device

Contact your HCP if your symptoms continue or worsen.

NOTE: This list is not all inclusive. Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.