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electrocore, based in Basking Ridge, New Jersey, has received the first FDA clearance for a product designed to prevent cluster headaches. The non-invasive gammaCore nerve nerve stimulation system (nVNS) was previously approved for the treatment of already-occurring pain related to migraines and episodic headaches. The new authorization means that doctors can also prescribe it for prevention purposes.
The latest version of the device, called gammaCore Sapphire, features a couple of electrodes placed on the neck, at the location of the vagus nerve. The device sends an electric current through the skin to the nerve and to the brain, disrupting the processes causing certain types of pain.
The device, the size of a smartphone, is small enough to be transported and the treatment can be administered at will and as needed. There does not seem to be any serious side effects known from this type of treatment, so it seems safe for repeated and regular use, provided it is used by adults.
Here are some data from the studies that led to this last authorization, according to electroCore:
This authorization was corroborated by the results of two studies, including the PREVA pivotal study (a preliminary study on the acute treatment of chronic acute headache), a prospective, open-label, controlled, randomized clinical trial that demonstrated safety and the effectiveness of gammaCore as adjuvant therapy. therapy for the preventive treatment of cluster headache. The second study reviewed by the FDA was a retrospective real-world study of the daily clinical and preventive use of gammaCore in the treatment of cluster headaches.
In the PREVA study, patients intending to treat (ITT) who received standard treatment and gammaCore (SoC plus nVNS, n = 45, control, n = 48) during the randomized phase experienced a greater reduction compared to baseline (-5.9) weekly cluster attacks compared to those receiving standard therapy (-2.1), for an average therapeutic gain of 3.9 fewer cluster attacks per week (P = 0.02). In the site-adjusted model, mean therapeutic gain was 4.2 fewer attacks per week (p = 0.02).
In addition, 40% of patients who received gammaCore in addition to standard care experienced a reduction of at least 50% in weekly clustering attacks, compared to 8.3% of patients receiving standard care alone (P<0.001).
In addition, the frequency of abortion drug use decreased by 57% in patients treated with gammaCore plus standard therapy (P<0.001), whereas patients who received standard treatment alone did not experience a substantial reduction in aborted drug use (P= 0.59).
Here is a video showing how to use the gammaCore Sapphire, the latest version of nVNS electroCore therapy:
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Flashbacks: Stimulation of the vagus nerve for the mbades: Interview with J.P. Errico, CEO of electroCore …; GammaCore Sapphire Helps Control Migraines and Cluster Headaches: Now Available in the US …; The personal non-invasive VNS of gammaCore is licensed against episodic headaches …
Product Page: gammaCore …
Via: electroCore …
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