Healthcare technology company electroCore has announced that the National Institute for Health and Care Excellence (NICE) has published a positive Medtech Innovation Briefing (MIB) regarding its non-invasive vagus nerve stimulator (nVNS), gammaCore, for the treatment of cluster headaches.
The opinions of four clinical experts and advocacy group Migraine Trust were consulted in the development of the MIB, a report developed by NICE to advise the NHS on which medical devices and technologies it should adopt.
The report combined recently published evidence to surmise that the use of gammaCore alongside current standards of care may be more effective than standard of care alone in the treatment of cluster headaches. Clinical specialists have proposed that gammaCore could be a suitable treatment for patients who have not responded to, or cannot tolerate current treatments. Report contributors also agreed that gammaCore was innovative and has the potential to save the NHS money by reducing the cost of treating cluster headaches.
The gammaCore device has been designed to treat and prevent cluster headaches and migraines in adult patients. It works by modifying pain signals by stimulating the vagus nerve with a mild electrical signal. ElectroCore wanted the device to be hand-held and portable so that patients could treat cluster headaches at home or at work and pressure on hospitals could potentially be alleviated.
The report contributors noted that the use of gammaCore has led to improvements for some patients with cluster headaches, allowing them to return to work and resume normal activities. It is also stated that gammaCore is easy to use and does not require surgical implantation or clinical monitoring.
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The Walton Centre consultant neurologist Dr Nicholas Silver said: “The NICE publication draws on significant clinical and research experience that recognises gammaCore as an effective, non-invasive handheld device with no known serious side effects. This is a great step forward as it will undoubtedly significantly improve the lives of many sufferers.”
A cluster headache is an excruciating primary headache disorder that has been referred to as a ‘suicide headache’ due to the severity of the pain it can cause. The NHS recently recognised cluster headaches as one of the top 20 most painful conditions known to man. Cluster headaches are estimated to cost the NHS in England more than £10,000 a year per patient, and they are thought to affect around 66,000 people in the UK. The disorder is less likely to be recognised in women so many patients suffer for years without a diagnosis.
electroCore CEO Francis Amato said: “We are encouraged by the findings of the report which reiterate that gammaCore is an effective treatment option for adults with this highly debilitating condition.
“Healthcare organisations using gammaCore can help to empower patients to take control of their condition by self-administering nVNS therapy. electroCore will continue to partner with NICE to ensure that our technology is routinely available to eligible patients on the NHS.”