BlueWind Medical, developer of a wireless neuro-stimulation device to treat multiple clinical indications, such as back pain, peripheral neuropathic pain, incontinence (OAB), epilepsy, and more, announced today the completion of patient enrolment for an Overactive Bladder (OAB) study which is currently being conducted to support CE Mark submission.
Thirty-six patients were successfully enrolled in four medical centres in the Netherlands and the United Kingdom.
About five million people, in the US alone, suffer from OAB and may benefit from emerging solutions such as BlueWind’s miniature neuro-stimulation device.
The OAB-1000 neuro-stimulator is implanted near the tibial nerve in the lower leg in a minimally invasive procedure under local anaesthesia. The miniature device electrically stimulates the tibial nerve, which is known to influence urinary function. Individual parameter settings are determined by the physician according to user’s sensations in order to help achieve normal urinary control relieving the need for frequent clinic visits.
"The implantation of BlueWind’s innovative implant was simple and smooth, and it was very easy to activate and use the device. Patients in Europe will benefit from its quality, flexibility and ease of use at home. During the screening phase of the study, we did not encounter any difficulties in enrolling patients, as they were convinced immediately," said Dr. J Heesakkers, a study investigator from Radboud Medical Center, Nijmegen, Netherlands.
"Mostly they liked the idea of having such a small implant in such a short procedure and then having the freedom of the option to self-control the treatment at home. The patients were relieved from the burden of logistics associated with clinic therapy."
"The future of neurostimulation is in miniaturization and patient empowerment," said Guri Oron, BlueWind’s CEO. "Today, neurostimulators that treat OAB are large and require complex and expensive surgery. We believe that in order to treat most patients, devices that are significantly smaller and simpler to implant will be required and BlueWind is currently completing the development of an injectable stimulator for that purpose."
"This is already the second indication for which we have collected clinical data to support CE mark submission. We are very pleased with the clinical study conductance so far and the performance of the device that can significantly improve the quality of life of patients suffering from OAB and other indications as peripheral neuropathic pain," said Efi Cohen Arazi, CEO of Rainbow Medical and chairman of the board of BlueWind Medical.
Initial clinical results of the study are expected to be announced at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) conference in New Orleans in February of 2016.