BlueWind RENOVA iStim™ for the treatment of Overactive Bladder (OAB)

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 a simple 30-minute procedure, 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™

Bluewind Renova Product

Stimulator

Bluewind Renova Product

Patient Wearable

Bluewind Renova Product

Clinician Programmer

General

General

Patient wearable, worn on the ankle

Implant dimensions

Implant dimensions

Volume: 0.3cc
Diameter: 3.4mm

Indication

Indication

For the treatment of patients with Overactive Bladder and associated symptoms of urinary urgency and frequency, with or without urge incontinence.

Procedure

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

Treatment protocol

Daily, 30 minutes self-administered treatment while carrying on normal daily activities.

Regulatory status

Regulatory status

CE Marked. USA: Investigational device. Limited by U.S. Federal Law to investigational use.

Clinical data

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

Mean improvment from baseline

0
5
10
15
20
25
30
35
40
1 Month
3 Months
6 Months

HRQL total (n=34)

0
5
10
15
20
25
30
35
40
1 Month
3 Months
6 Months

Symptoms severity (n=34)

The mean improvement in symptom severity was 35.7 at the 6 months FU.

Improvement in urinary incontinence episodes

Clinical Perfomance Success (%)
0
20
40
60
80
100
14.3
42.9
7.1
1M
13.8
24.1
20.7
3M
6.9
24.1
27.6
6M
100%
50%-99%
30%-50%

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

BlueWind’s Competitive Advantages

Miniature implant

Miniature implant

Miniature implant

The BlueWind Medical neurostimulator is significantly smaller than conventional devices. Advanced technologies allow the transformation to a minimally invasive procedure.

Targeted

Targeted

Targeted

The neurostimulator provides localized targeted treatment vs. widespread stimulation which may unnecessarily stimulate large areas.

Battery-less

Battery-less

Battery-less

Patient wearable provides wireless power without the need for repeated surgeries to replace a depleted battery.

Closed loop mechanism

Closed loop mechanism

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 safe

MR safe

MR conditional for static magnetic field of 1.5 and 3 Tesla.

Leadless

Leadless

Leadless

No wires are tunneled under the skin thus avoiding lead migration or fracture.