CE Mark For Cerbomed’s Transcutaneous Vagus Nerve Stimulation Pain Relief Indication

In short

Germans medical device company Cerbomed GmbH has received CE mark clearance for the application of transcutaneous Vagus Nerve Stimulation (t-VNS) in pain relief therapy.

Background

Transcutaneous Vagus Nerve Stimulation is intended for patients suffering from various difficult-to-treat neurological and psychiatric diseases. The t-VNS therapy uses the fact that a branch of the vagus nerve is located directly under the skin in areas of the outer ear and therefore can be stimulated through the skin (transcutaneously) with electrical impulses.

Cerbomed is an innovative medical device company located in Erlangen, Germany, that focuses on neuromodulation. The company, founded in 2005, focuses on transcutaneous Vagus Nerve Stimulation (t-VNS), which may offer an attractive therapy option for patients with hard-to-treat neurological and psychiatric illnesses. The therapy gained CE mark approval for use in refractory epilepsy last year.

Studies

A randomised study on pain processing was conducted in cooperation with the University of Regensburg in 2011 which demonstrated a significant reduction of perceived mechanical pain in healthy volunteers with t-VNS (Busch et al., Brain Stimulation, in press).

In a second randomised controlled study, pain processing in the right and left hand was examined on 49 healthy volunteers on three different days. The effect of a dextral t-VNS after stimulation of the left ear was also examined for the first time. In both cases, t-VNS reduced pain perception following mechanical stimuli significantly.

Company comments

“The current results and literature data form the foundation of the clinical study on the effect of t-VNS in chronic migraine treatment. It is conducted by the Headache Center of the Neurological Department at the Großhadern Hospital in Munich”, explains Prof. Dr. Jens Ellrich, Chief Medical Officer of cerbomed GmbH. The randomised controlled study is examining the efficacy of t-VNS on 98 patients suffering from chronic migraine.

Source: Cerbomed GmBH, Business Wire