Bluewind receives CE approval for wireless bladder controller
June 28, 2016
Bluewind Medical has received the CE Mark for its OAB-1000, a miniature wireless neurostimulator to treat overactive bladder (OAB).
An estimated 66 million people in the European Union and 43 million in the USA suffer from OAB, a disease that adversely affects quality of life and social life of patients. So far, neurostimulation treatment, while effective, requires an invasive surgical procedure to implant a stimulation lead and a neurostimulator in the pelvic area.
The OAB-1000 is a wireless, battery-less neurostimulator that is 90 per cent smaller than typical neurostimulators on the market. The miniature device will allow physicians to treat OAB 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, 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.
"Today, neurostimulators that treat OAB are large, bulky, and require complex and expensive surgery," said Guri Oron, CEO of Israel-based Bluewind. "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."
Earlier this year, Bluewind successfully completed a thirty-six patients clinical study in four medical centres in the Netherlands and UK to study the safety and performance of the OAB-1000.
"The device was easy to implant, activate and use," said Sohier Elneil from UCL and NHNN hospitals in London. "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. The patients were also relieved from the burden of logistics associated with therapy in the clinic."
The company plans to present the complete results of this OAB study at the International UroGynecological Association conference in South Africa in August and at the International Continence Society conference in Tokyo in September.
Bluewind Medical was founded in 2010 by the Israeli innovation and investment company Rainbow Medical.
"We are very pleased with Bluewind's achievement of CE Mark for OAB," said Efi Cohen Arazi, CEO of Rainbow Medical. "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."