Bluewind Medical wins CE Mark for Vivendi mini-neurostim pain implant

Neurostim developer Bluewind Medical said today it won CE Mark approval in the European Union for its Vivendi neurostimulation device designed to treat peripheral neuropathic pain.

The newly cleared neurostim device is 90% smaller than ‘typical’ neurostimulators on the market, the Israeli company said, and is designed to be implanted in close proximity to the Tibial nerve so it can apply electrical stimulation to the nerve to ease or mask pain.

“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,” CEO Guri Oron said in a press release.

The procedure to implant the device is minimally invasive and lasts approximately 30 minutes, and the device is designed to be powered wirelessly by an external control unit worn on the ankle.

Patients can self administer treatment with the device for up to 8 hours a day, the company said.

“The Bluewind Vivendi system provides a solution to many patients that have no other relief. The small implant was very easy to implant, and very easy for the patients to activate and use. Patients can use it whenever they have pain and it provides immediate and sustainable pain relief,” Jean-Pierre Van Buyten of Belgium’s Multidisciplinary Pain Centre AZ Nikolaas said in prepared remarks.

Bluewind touted a multi-center study of the device which reported that 83% of patients implanted with the device reported a greater than 50% reduction in VAS pain scores after 6 months.

“Bluewind Vivnedi is our second product approved this year and it shows the power of the platform to expand to multiple indications and separate markets. The company now have regulatory approval for two products and will continue to invest to further extend the usage of its platform,” Bluewind board chair & Rainbow Medical CEO Efi Arazi said in a prepared statement.

In June, Bluewind said it won CE Mark approval in the European union for its OAB-1000 system designed to treat overactive bladder through wireless neurostimulation.

The OAB-1000 device is a wireless, battery-less neurostimulator that is implanted in a minimally invasive procedure near the tibial nerve in the lower leg. The device stimulates the tibial nerve, which influences urinary function, and is powered by an external power and control unit, according to the company.

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