BlueWind Medical Announces CE-Mark for its VIVENDI

HERZLIYA, Israel --- BlueWind Medical, developer of a miniature wireless neurostimulation platform to treat multiple clinical indications, announced today that the company has received CE-Mark for the BlueWind's VIVENDI miniature wireless neurostimulator to treat Peripheral Neuropathic Pain (PNP). This is the second product BlueWind has received CE-Mark based on its advanced neurostimulation platform, after obtaining few months ago CE-Mark for treatment of an Over Active Bladder.

An estimated 8 million people in Europe and 6 million in the USA, suffer from PNP, including about 14% of all people with diabetes. PNP is a debilitating pain that impairs patient's quality of life, daily functioning, sleeps, work productivity and more. The most common treatment for PNP is pharmacological, including intensive use of Opioids, and PNP is one of the key contributors to the Opioid epidemic in the US.

The BlueWind VIVENDI System is a wireless, battery-less neurostimulator which is 90% smaller than typical neurostimulators in the market. The miniature device is implanted in close proximity to the Tibial nerve and by applying electrical stimulation to the nerve, helps to ease or mask the pain sensation. The device is implanted in a minimally invasive simple procedure lasting only about 30 minutes, and is powered wirelessly by an external control unit, conveniently worn as needed by the patient on the ankle.

Patients self-administer the treatment using the wearable device as often and for as long as they need, and up to 8 hours a day. The reduction in pain is typically immediate and lasts between 30 minutes to a few hours post stimulation. In a multi-center clinical study performed in leading pain centers in Europe with 13 implanted patients, 83% of patients have reported more than 50% reduction in VAS pain scores over 6-month follow-up period.

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