GammaCore Sapphire, the newest version of gammaCore—a noninvasive vagus nerve stimulator—is now available in the United States to treat patients with migraine and episodic cluster headache.
GammaCore Sapphire, the newest version of gammaCore—a noninvasive vagus nerve stimulator (nVNS)—is now available in the United States to treat patients with migraine and episodic cluster headache, according to a press release from bioelectronic medicine company, electroCore.
gammaCore represents the first FDA-approved nVNS device for the acute treatment of pain associated with migraine and episodic cluster headache. The device can be self-administered by patients, as needed, for their pain without the potential side effects of commonly prescribed medicines, according to electroCore. The device is placed on the patient’s neck, over the vagus nerve, and gammaCore stimulates the nerve’s fibers, reducing pain.
The updated gammaCore is a smaller handheld device easy for patients to grip, smoother stimulation surfaces for easy placement over the vagus nerve, intensity buttons on the side of the device to allow for therapy adjustments, and a bright display to communicate status information, even in the dark.
“gammaCore Sapphire offers more convenience to patients with an enhanced designed and added functionalities that make the therapy application more seamless and even more patient-centric than the device’s previous generation,” said Dan Duhart, chief commercial officer of electroCore.
The device was built with added functionality intended for multi-year use, coming with a rechargeable function and reloadable refill capacity. The device can be activated monthly with a prescription-only authorization code, delivered through a radio-frequency identification card that patients receive by mail.
Physicians must prescribe gammaCore, and each device can treat multiple headaches per day, with up to 24 stimulations per day.
“Constantly innovating to deliver the next-generation device is just one example of our commitment to providing relief to patients suffering from the debilitating pain of migraine and episodic cluster headache,” said Duhart.
The company notes that the device has not shown to be effective as a prevention method for chronic or episodic cluster headache or migraine and that long-term effects of the device have not been evaluated.
While gammeCore has not been shown to be effective as prophylactic treatment, research has indicated that noninvasive single-pulse transcranial magnetic stimulation may be an effective, well-tolerated treatment option for migraine prevention. In 2014, eNeura’s SpringTMS device received FDA approval for the acute treatment of migraine with aura. This year, a study yielded positive results with the device as a prevention method and led to the FDA’s clearance of the device.