Israel-based medical technology company BlueWind Medical has secured the CE-Mark for its VIVENDI miniature wireless neurostimulator to treat Peripheral Neuropathic Pain (PNP).
The BlueWind VIVENDI System is a wireless, battery-less neurostimulator smaller than the conventional neurostimulators in the market.
Implanted close to the Tibial nerve, the device will help ease or mask the pain sensation by emitting electrical stimulation to the nerve.
The miniature device is implanted in a minimally invasive simple procedure which takes about 30 minutes, and is wirelessly powered by an external control unit, worn on the ankle.
The wearable device allows the self-administration by the patients according to their needs.
It results in pain relief with an immediate effect and remains between 30 minutes to a few hours post stimulation.
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's miniature and wireless neurostimulators are significantly smaller, allow for a simple implant procedure, precise targeting of the pain location, and are easier for patients to use at home."
The neurostimulator demonstrated its efficacy in reducing pain in 13 implanted patients during a multi-centre clinical study performed in leading pain centres in Europe.