BlueWind Medical receives CE mark for first-to-market miniature overactive bladder wireless neurostimulator

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Bluewind Medical  has received CE marking for its OAB-1000 System, the first in the world miniature wireless neurostimulator to treat overactive bladder (OAB).

According to a company release, the Bluewind Medical OAB-1000 is a wireless, battery-less neurostimulator which is 90% smaller than typical neurostimulators in the market. The miniature device is designed to allow physicians to treat overactive bladder with a minimally invasive simple procedure lasting only 30 minutes, placing it near the tibial nerve, in the lower leg. The device electrically stimulates the tibial nerve, which influences urinary function, and is powered wirelessly by an external control unit, conveniently worn by the patient. Patients wear the external control unit for only 30 minutes, and can use it while performing their daily tasks without interruption. Since the implantable neurostimulator is battery-less, it does not require invasive replacement like conventional devices. This new treatment paradigm, transforms the way patients are treated today, relieves them from the need for frequent clinic visits, and allows them to control their own healing process.

Earlier this year, BlueWind Medical successfully completed a thirty-six patient clinical study in four medical centres in the Netherlands and UK to study the safety and performance of the OAB-1000. The company plans to present the complete results of this overactive bladder study, in the International UroGynecological Association (IUGA) conference in Cape Town, South Africa in August 2016 and in the International Continence Society (ICS) conference in Tokyo, Japan in September 2016.

“The device was easy to implant, activate and use,” says S Elneil, UCL and NHNN hospitals, London, UK. “European participants in the study liked the idea of such a small implant and a very short procedure; they were very favourable to having the flexibility and sense of control by treating themselves at home,” adds Elneil. “The patients were also relieved from the burden of logistics associated with therapy in the clinic.”