BlueWind RENOVA iStim -Transform Neuromodulation Therapy for the Treatment of Overactive Bladder (OAB)
Neuromodulation is a long standing therapy with years of accumulated experience and demonstrated effectiveness. Now, physicians and patients are ready for a new product in a form factor that will unlock the enormous potential of the therapy.
Overactive Bladder has traditionally been treated by both Sacral Neuromodulation (SNM) and Percutaneous Tibial Nerve Stimulation (PTNS) and these therapies have been recognized as safe and effective treatment for OAB. SNM, albeit an effective therapy, requires a complex implantation procedure of a large device and extension leads and there are considerable complications associated with the procedure, which requires full anesthesia, and the treatment. PTNS is less invasive, but is administered only at the physician’s clinic and therefore it is an inconvenient treatment, which limits the accessibility and adoption of therapy. BlueWind Medical’s RENOVA iStim™ is an implantable tibial neuromodulation device. Its unique design allows for the procedure to be done under local anesthesia. Routine use of the RENOVA iStim™ is simple and personalized in the comfort of the patient’s home without the need to frequently visit the clinic.
BlueWind RENOVA iStim
- Stimulator
- Patient Wearable
- Clinician Programmer
General
Patient wearable, worn on the ankle
Implant dimensions
Volume: 0.3cc
Diameter: 3.4mm
Indication
For the treatment of patients with Overactive Bladder and associated symptoms of urinary urgency and frequency, with or without urge incontinence.
Procedure
The stimulator is implanted through a small incision and is fixed in place with sutures. 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.
Treatment protocol
Daily, 30 minutes self-administered treatment while carrying on normal daily activities.
Regulatory status
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 iStim™.
Symptoms improvement after 6 months
< 30% 30% - 50% > 50%
70.6% of patients had greater than 50% reduction in their symptoms or a return to normal voiding
Improvement in Health Related Quality of Life and Symptom Severity
The mean improvement in symptom severity was 35.7 at the 6 months FU.
Improvement in urinary incontinence episodes
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 opportunity for growth in the $700 Million Overactive Bladder (OAB) Neuromodulation market is vast.
14.3 Million patients in the US suffer from OAB and are refractory to medication, of which only 150,000 patients are treated with neuromodulation. This is primarily due to the complexity, invasiveness, complications and cost of existing solutions. BlueWind Medical is poised to capitalize on this market need, leveraging its technological advantages and unique design to treat many more patients.
Miniature implant
The BlueWind Medical neurostimulator is significantly smaller than conventional devices. Advanced technologies allow the transformation to a minimally invasive procedure.
Targeted
The neurostimulator provides localized targeted treatment vs. widespread stimulation which may unnecessarily stimulate large areas.
Battery-less
Patient wearable provides wireless power without the need for repeated surgeries to replace a depleted battery.
Closed loop mechanism
The BlueWind RENOVA has a closed loop mechanism which ensures consistent and dependable stimulation maintaining patient’s convenience in everyday activities.
MR safe
MR conditional for static magnetic field of 1.5 and 3 Tesla.
Leadless
No wires are tunneled under the skin thus avoiding lead migration or fracture.
Fully featured
The BlueWind Medical device incorporates the latest technological advancements in neuromodulation.
Expanding access
The easier procedure and smaller implant support a growing number of indications and increased access to therapy.