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     111  0 Kommentare electroCore Announces 510(k) Clearance of gammaCore Non-Invasive Vagus Nerve Stimulation (nVNS) to Treat Adolescent Migraine - Seite 2

    About electroCore, Inc.
    electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.

    For more information, visit www.electrocore.com.

    About gammaCoreTM
    gammaCoreTM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients. 

    gammaCore is FDA cleared in the United States 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, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

    • Safety and efficacy of gammaCore have not been evaluated in the following patients:
      • Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
      • Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
      • Pregnant women
      • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

    • Patients should not use gammaCore if they:
      • Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
      • 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 (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
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    electroCore Announces 510(k) Clearance of gammaCore Non-Invasive Vagus Nerve Stimulation (nVNS) to Treat Adolescent Migraine - Seite 2 FDA clearance expands gammaCore label to include the acute and preventive treatment of migraine in adolescents 12 to 17 years of ageROCKAWAY, N.J., Feb. 16, 2021 (GLOBE NEWSWIRE) - electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic …