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Overactive Bladder has traditionally been treated by both Sacral Nerve Stimulation (SNS) and Tibial Nerve Stimulation and these therapies have been recognized as safe and effective treatment for OAB. SNS, albeit an effective therapy, requires a complex implantation procedure of a large device and extension leads and there are considerable complications associated with both the procedure and the treatment. Tibial stimulation is less invasive, but is administered only at the physician’s clinic and therefore it is an inconvenient treatment which reduces the frequency of treatment. BlueWind Medical’s RENOVA™ also uses tibial stimulation, but its unique design allows the patient a simple and personalized treatment in the comfort of their home without frequently visiting the clinic.
Patient wearable, worn on the ankle
For the treatment of patients with Overactive Bladder and associated symptoms of urinary urgency and frequency, with or without urge incontinence.
The stimulator is implanted through a small incision and is fixated with a simple suture. There is no need to expose the target nerve, as the device is placed in the vicinity of the neurovascular bundle. The implantation procedure lasts approximately 30 minutes and is performed under local anesthesia.
Daily, 30 minutes self-administered treatment while carrying on normal daily activities.
CE Marked USA: Investigational device. Limited by U.S. Federal Law to investigational use
In a pilot clinical study conducted in Europe, BlueWind Medical demonstrated the safety and performance of BlueWind RENOVA™.
Symptoms improvement after 6 months
70.6% of patients had greater than 50% reduction in their symptoms or a return to normal voiding
Mean improvment from baseline
The mean improvement in symptom severity was 35.7 at the 6 months FU.
In the urinary incontinence group, the percentage of dry subjects continuously grew after activation from 7.1% 1 month after activation through 20.7% at the 3 months follow-up to 27.6% at the 6 months follow-up. At the 1 month follow-up there was an immediate significant impact of the therapy on subjects where 50% of subjects reported more than 50% Success Response*.
* Success response was defined as ≥50% improvement in leaks/day
The BlueWind Medical neurostimulator is miniature and therefore has a much lower complication rate than sacral nerve stimulation devices
The neurostimulator provides localized targeted treatment vs. widespread stimulation which may unnecessarily stimulate large areas
Lifelong neurostimulator - no need for repeated surgeries to replace the depleted battery
The BlueWind RENOVA™ models have a closed loop mechanism which ensures consistent and dependable stimulation maintaining patient’s convenience in everyday activities
MR conditional for static magnetic field of 1.5 and 3 Tesla
No wires are tunneled under the skin thus avoiding lead migration or fracture