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ElectroCore Announces Positive Coverage Policies of gammaCore Issued by Highmark
"This coverage announcement marks a significant step forward. Highmark’s updated medical policy opens a new path to treatment access for many patients suffering from migraine and cluster headache,” said
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy
gammaCore is the only therapy
gammaCore is available by prescription only and patients should speak with their doctor about whether gammaCore is right for them.
gammaCore™ (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 (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
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.
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 and rheumatology. The company’s initial targets are the preventative treatment of cluster headache and acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.