Miniature Wireless Neurostimulator For Peripheral Neuropathy Receives CE Mark
Engineers at BlueWind Medical have received CE Mark approval for a wireless neurostimulator small enough to effectively treat peripheral neuropathic pain (PNP), a common side effect of diabetes. The Vivendi is implanted through a minimally invasive procedure and provides targeted pain relief that is controlled externally, by the patient, at home.
PNP is a condition caused by nerve damage to the peripheral nervous system and affects over 20 million Americans, 13.8 million of whom are diabetics, according to the National Foundation for Peripheral Neuropathy. Common symptoms include loss of sensation, tingling, cramping, and chronic pain, which is currently managed by medication. Until now, neurostimulation, a pain-relieving alternative to prescription drugs, has not been an option for PNP because of the size and complexity of devices currently on the market.
BlueWind Medical’s Vivendi is 90 percent smaller than existing neurostimulators and is powered wirelessly by an external power source, worn on the ankle. According to a press release, the device is implanted near the tibial nerve in a minimally invasive procedure lasting less than 30 minutes. Patients can easily control the device at home, adjusting the pain-relief as needed, for up to eight hours per day.
European regulators based their approval of the device on a clinical study of 13 patients implanted with Vivendi, which demonstrated a 50 percent reduction in visual analogue scale (VAS) pain scores over 6 months for 83 percent of patients. Jean-Pierre Van Buyten, chairman of the Pain Center AZ Nikolaas in Belgium, noted that the system was simple to implant and provided “sustainable relief” for patients who often have no other pain-relief solution.
BlueWind CEO Guri Oron called Vivendi a “new treatment paradigm” for PNP management, which relieves the patient “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.”
“BlueWind Vivendi is our second product approved this year, and it shows the power of the platform to expand to multiple indications and separate markets,” said Efi Cohen Arazi, CEO of Rainbow Medical and Chairman of the Board of BlueWind Medical, referencing BlueWind’s recent CE Mark for a similar neurostimulator indicated for overactive bladder. “The company now has regulatory approval for two products and will continue to invest to further extend the usage of its platform.”
Rainbow Medical is an investment company funding startups based on the developments of Israeli entrepreneur Yossi Gross. Arazi told Globes that his company works closely with big-name investors — such as Sony, Medtronic, and Abbott Laboratories — to develop customized products. Through their investment in Rainbow Medical, corporate sponsors can direct product development and have indirect stakes in Rainbow’s portfolio companies, including BlueWind.