Neurostim developer Bluewind Medical said today 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.
“Today, neurostimulators that treat OAB are large, bulky, and require complex and expensive surgery. BlueWind’s implantable microstimulators are significantly smaller, allow for a simple implant procedure and are easier for patients to use at home. This is the first product out of many in our pipeline that will transform Neurostimulation and by that, will enable the treatment of millions of additional patients,” CEO Guri Oron said in a prepared statement.
The Israel-based company completed a 36-patient, multi-center clinical trial of the device across earlier this year, it reported, with plans to present thre results of the study at the International UroGynecological Association’s coference in Cape Town, South Africa in August.
“The device was easy to implant, activate and use. European participants in the study liked the idea of such a small implant and a very short procedure; They were very favorable to having the flexibility and sense of control by treating themselves at home. The patients were also relieved from the burden of logistics associated with therapy in the clinic,” Dr. S Elneil of London’s NHNN hospitals said in a prepared release.
“We are very pleased with BlueWind’s achievement of CE Mark for OAB. This achievement is a testament for the team dedication, high quality of work and ingenuity. We plan to make these products available for physicians and patients in the near future,” board chair Efi Cohen Arazi said in a press release.
