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

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.

BlueWind RENOVA™, Injectable Model

Delivery System

Delivery System

Stimulator

Stimulator

Patient Wearable

Patient Wearable

Clinician Programmer

Clinician Programmer

Patient Remote Control

Patient Remote Control

General

General

Patient wearable, worn on the ankle

Implant dimensions

Implant dimensions

Volume: 0.15cc

Diameter: 2.6mm

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 injected into place using a designated delivery system and can be positioned under ultrasound or active stimulation guidance. The insertion procedure takes approximately 20 minutes.

Regulatory status

Regulatory status

Investigational device

Treatment protocol

Treatment protocol

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

BlueWind RENOVA™, Implantable Model

Stimulator

Stimulator

Patient Wearable

Patient Wearable

Clinician Programmer

Clinician Programmer

Patient Remote Control

Patient Remote Control

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 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.

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™.

 

 

 

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 miniature and therefore has a much lower complication rate than sacral nerve stimulation devices

Targeted

Targeted

Targeted

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

Battery-less

Battery-less

Battery-less

Lifelong neurostimulator - no need for repeated surgeries to replace the depleted battery

Closed loop mechanism

Closed loop mechanism

Closed loop mechanism

The BlueWind RENOVA™ models have 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