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BlueWind Medical’s Vivendi neurostimulator wins CE-mark approval to treat peripheral neuropathic pain

BlueWind Medical has received CE mark approval for its Vivendi miniature wireless neurostimulator for the treatment of peripheral neuropathic pain (PNP).

Vivandi is a wireless and battery-less neurostimulator, which can be implanted in close proximity to the Tibial nerve.

By applying electrical stimulation to the nerve, the device will ease or mask the pain sensation. It is implanted in a minimally invasive procedure that takes up to 30 minutes.

According to the company, the patients can self-administer the treatment using the wearable device for up to eight hours per day.

In June, the firm also secured CE mark approval for its OAB-1000 system, which is a wireless and battery-less neurostimulator for the treatment of overactive bladder (OAB).

BlueWind CEO Guri Oron said: "This new treatment paradigm, transforms the way patients are treated today, relieves them from the need for Opioid or other pharmacological treatments and allows them to control their own healing process.

"Until today, it was not possible to locally treat chronic peripheral pain with neurostimulators due to the size and complexity of existing neurostimulators.”

BlueWind Medical board chairman Efi Cohen Arazi said: "The company now have regulatory approval for two products and will continue to invest to further extend the usage of its platform."

BlueWind is engaged in the development of a platform technology of miniature wireless neurostimulators, which can be used to treat multiple indications.