BASKING RIDGE, N.J., July 18, 2017 /PRNewswire/ -- electroCore, a neuroscience and technology company dedicated to improving patient outcomes through technological advancement, announced today the commercial launch of gammaCore® (non-invasive vagus nerve stimulator) for the acute treatment of pain associated with episodic cluster headache in adult patients in the United States (U.S.). gammaCore is the first non-invasive, hand-held medical device applied at the neck and sends gentle, patented electrical stimulation through the skin to activate the vagus nerve, resulting in the reduction of pain.
"We are proud to bring gammaCore to the U.S. market, as it provides episodic cluster headache sufferers with a much-needed treatment option for this rare and often debilitating condition," said Francis R. Amato, Chief Executive Officer of electroCore. "The commercial launch also signifies an important milestone for electroCore, marking the first marketed product for the company in the U.S."
Patients can receive the device by enrolling in gammaCore Patient Registry (GPR), a non-research registry intended to examine the patient experience with gammaCore. As part of the registry, those eligible may receive two months of gammaCore treatment at no cost to the patient, in return for sharing information about their experience with the device along with periodic quality-of-life, self-reported outcomes. Additional key offerings of GPR include:
- An interactive, online tracker to record information about cluster attacks as they occur
- Hands-on training for how to use gammaCore from a GPR coordinator
- Access to online and in-person support from a care specialist throughout the duration of treatment
- Co-pay assistance for up to one year
GPR will be offered through a select group of headache centers across the country. In order to participate in GPR, adult patients must be diagnosed with episodic cluster headache and selected by their participating healthcare provider (HCP) as appropriate candidates. gammaCore is available by prescription only, and detailed instructions for physicians about how to prescribe gammaCore are available at www.gammaCore.com.
The U.S. Food and Drug Administration (FDA) released gammaCore for use on April 14, 2017. gammaCore is also currently in use outside of the U.S., including in the European Union. For more information on gammaCore and how to access the registry, please call 888-903-CORE or visit www.gammaCore.com.
About Cluster Headache
Cluster headache is a rare but extremely painful primary headache disorder characterized by recurring unilateral attacks.i The condition is the least common type of headache disorder, occurring in approximately one to two out of 1,000 individuals.i Cluster headache predominantly affects males, with symptoms typically manifesting by the age of 30.ii Frequently nicknamed "suicide headache" due to the severity of pain associated with their occurrence, cluster headache bouts occur rapidly and with variable frequency but often at the same time each year or day and are often more frequent at night.iii Those at greater risk of cluster headache include heavy smokers and those with a family history of the condition.i
gammaCore® (nVNS) is the first non-invasive, hand-held medical device applied at the neck that acutely treats the pain associated with episodic cluster headache in adult patients through the transmission of a mild electrical stimulation to the vagus nerve 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 standard of care. 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 released/cleared in the U.S. for the acute treatment of pain associated with episodic cluster headache in adult patients. gammaCore is currently in use outside of the U.S., including in the European Union, where it is CE-Marked.
IMPORTANT SAFETY INFORMATION REGARDING GAMMACORE
- The safety and effectiveness of the gammaCore non-invasive vagus nerve stimulator has not been established in the acute treatment of chronic cluster headache.
- This device has not been shown to be effective for the prophylactic treatment of chronic or episodic cluster headache.
- The long-term effects of the chronic use of the device have not been evaluated.
- Safety and efficacy of gammaCore has not been evaluated in the following patients, and therefore 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 comprehensive. Please refer to the gammaCore Instructions for Use for all important warnings and precautions before using or prescribing this product.
gammaCore is available by prescription only. U.S. Federal Law restricts this device to sale by or on the order of a licensed healthcare provider.
electroCore, LLC is a U.S.-based neuroscience and technology company dedicated to improving patient outcomes through technological advancement and focused on developing non-invasive vagus nerve stimulation therapy for the treatment of multiple conditions in neurology, inflammation, and metabolic syndrome. The company's initial target is the treatment of primary headaches (migraine and cluster headache) and the associated chronic co-morbidities of gastric motility, psychiatric, sleep, and pain disorders that drive disproportionately large direct and indirect costs within the healthcare system and society.
For more information, visit electrocore.com.
©2017 electroCore, LLC. All rights reserved.
electroCore, the electroCore logo, gammaCore, and The NeuroScience Company are trademarks of electroCore, LLC.
i "Cluster Headache." The Migraine Trust. The Migraine Trust, n.d. Web. 30 Nov. 2016. https://www.migrainetrust.org/about-migraine/types-of-migraine/other-headache-disorders/cluster-headache/.
ii "Disease & Conditions: Cluster Headaches"; Cleveland Clinic. Cleveland Clinic, 2016. Web. 30 Nov. 2016 http://my.clevelandclinic.org/health/diseases_conditions/hic_Cluster_Headaches.
iii International Headache Society. Dodick. Cephalalgia. 2000;20:787. Rozen. Headache. 2012;52:99. Physician Interviews. ClearView Analysis.
SOURCE electroCore LLC