ElectroCore, Inc.'s gammaCore Awards Five-Year Federal Supply Schedule Medical Equipment and Supply Contract
January 02, 2019 at 08:00 am EST
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electroCore, Inc. announced its non-invasive vagus nerve stimulation therapy, gammaCore, has been awarded a five-year Federal Supply Schedule Medical Equipment and Supply contract which will make gammaCore available in January to the over 21 million patients managed within the Department of Veteran’s Affairs, Department of Defense, Bureau of Prisons, Indian Health Services and Public Health Services. gammaCoreTM (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for: Adjunctive use for the preventive treatment of cluster headache in adult patients. The acute treatment of pain associated with episodic cluster headache in adult patients. The acute treatment of pain associated with migraine headache in adult patients. The safety and effectiveness of gammaCore (nVNS) have not been established in the acute treatment of chronic cluster headache gammaCore has not been shown to be effective for the preventive treatment of migraine headache The long-term effects of the chronic use of gammaCore have not been evaluated Safety and efficacy of gammaCore have not been evaluated in the following patients, and therefore it is NOT indicated for: Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device Patients diagnosed with narrowing of the arteries (carotid atherosclerosis) Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy) Pediatric patients, Pregnant women, Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia, Patients should not use gammaCore if they: Have a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck Are using another device at the same time.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company. It provides non-invasive vagus nerve stimulation (nVNS) technology platform. The Companyâs product categories include Handheld, personal use medical devices for the management and treatment of certain medical conditions such as primary headache, and Handheld, personal use consumer products utilizing nVNS technology to promote general wellness and human performance. Its products include gammaCore, Truvaga and TAC-STIM. Its gammaCore Sapphire, is a prescription medical device that is used for a variety of primary headache conditions. Its Truvaga is a personal use consumer electronics general wellness product that does not require a prescription and is available direct-to-consumer from electroCore at www.truvaga.com. The Companyâs TAC-STIM product is not a medical device and is not intended to diagnose, cure, mitigate, prevent, or treat a disease or condition.