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NICE Issues Draft Guidance on the Use of gammaCore for Cluster Headache
LONDON and BASKING RIDGE, N.J., July 09, 2019 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a global commercial-stage bioelectronic medicine company, today announced that the National Institute for Health and Care Excellence (NICE) has published draft guidance on the use of gammaCore, a non-invasive vagus nerve stimulator (nVNS) for preventing and treating cluster headache in adults, which concludes that “evidence supports the case for adopting gammaCore to treat cluster headache in the NHS. gammaCore reduces the frequency and intensity of cluster headache attacks and improves quality of life.” The full draft guidance can be found here.
In the draft guidance, NICE highlights that the use of gammaCore in addition to standard care therapy could save the NHS £450
“Cluster headache is a devastating disorder that affects around 100,000 people in the U.K.,” said
In order to finalize its medical technology guidance documents, NICE will solicit comments from stakeholders on the draft guidance. After the end of this consultation period, the review committee will meet to discuss whether to amend its draft recommendations in view of the consultation comments. Consultation on the draft gammaCore recommendations will close at
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 CE-marked in the
- The effectiveness of gammaCore (nVNS) has 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
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.
For more information, visit electrocore.com.