electroCore Announces Full Enrollment of TR-VENUS study of Non-Invasive Vagal Nerve Stimulation (nVNS) for the Acute Treatment of Stroke - Seite 2

“We congratulate and thank the investigators, patients and families that all supported the successful completion of study enrollment and we look forward to the data readout and what it tells us about nVNS’ potential as an acute treatment for stroke,” said Eric Liebler, Senior Vice President of Neurology at electroCore.

For complete details on the study design please see clintrials.gov: https://clinicaltrials.gov/ct2/show/NCT03733431?term=NCT03733431&d ...

About gammaCore
gammaCore (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, the acute treatment of pain associated with migraine headache in adult patients, and the prevention of migraine in 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. In 2019, NICE published an evidence-based Medical Technology Guidance document recommending the use of gammaCore for cluster headache within NHS England.

• 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)
  • Pediatric patients
  • 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)

In the US, the FDA has not cleared gammaCore for the treatment of pneumonia and/or respiratory disorders such as acute respiratory stress disorder associated with COVID-19. Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.