BlueWind Medical has won a CE mark for its miniature neurostimulation implant to treat peripheral neuropathic pain. The approval comes three months after the Israeli startup received a CE mark for its neurostimulator to treat overactive bladder.
The wireless, batteryless Vivendi neurostimulator is 90% smaller than neurostimulators currently on the market, according to the company. It is implanted near the tibial nerve during a minimally invasive procedure that takes 30 minutes, BlueWind said in a statement. powered by an external unit worn on the patient’s ankle, the device stimulates the nerve to alleviate pain. Because it’s batteryless, the patient does not need to undergo further surgeries to replace the device.
Patients use the external component to self-administer the treatment as needed. Pain reduction is usually immediate, BlueWind said, and lasts between 30 minutes and a few hours. In a clinical study involving 13 patients in Europe, 80% of patients reported a more than 50% decrease in VAS pain scores over 6 months after implantation.
Peripheral neuropathic pain affects about 8 million people in Europe and 6 million in the U.S., BlueWind said. It is most commonly treated with drugs, including opioids. An alternative, nonpharmacological treatment such as neurostimulation could help cut down on the intensive use of opioids to treat the condition.
"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,” said BlueWind CEO Guri Oron in the statement.