BlueWind VIVENDI™ for the treatment of Peripheral Nerve Pain (PNP)

Peripheral Nerve Pain is often treated with pain relievers, including the growing use of opioids. These drugs have many side effects, may be highly addictive and do not always completely relieve the pain. Rarely, patients who suffer from PNP are treated with Spinal Cord Stimulation (SCS), a therapy involving a complex implantation procedure of a large device and extension leads. There are considerable complications associated with both the procedure and the treatment of SCS.
BlueWind Medical’s VIVENDI™ provides the efficacy of pain relief through Neurostimulation in a minimally invasive product targeting the specific pain location. Unlike medication, VIVENDI™ does not have side effects and the treatment is reversible.

BlueWind VIVENDI™, Implantable Model

Stimulator

Stimulator

Clinician Programmer

Clinician Programmer

Patient Wearable

Patient Wearable

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

To aid in the management of chronic intractable pain

Procedure

Procedure

The stimulator is implanted through a small 5cm 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

Stimulation should be delivered as needed. Patient can decide when to turn the device on or off based on their pain levels.

Regulatory status

Regulatory status

Europe: CE marked

USA: Investigational Device. Limited by U.S. Federal Law to Investigational use

BlueWind VIVENDI™, 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

To aid in the management of chronic intractable pain

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 lasts approximately 20 minutes.

Treatment protocol

Treatment protocol

Stimulation should be delivered as needed. Patient can decide when to turn the device on or off based on physician’s instructions.

Regulatory status

Regulatory status

Investigational device

Clinical data

In a pilot clinical study conducted in Europe, BlueWind Medical demonstrated the safety and performance of BlueWind VIVENDI™.

 

 

 

Symptoms improvement after 6 months

< 30%
30% - 50%
> 50%

Over 80% of patients with more than 50% pain reduction at 6 months follow-up as compared to baseline

Pain Assessment by Pain Diary VAS score

VAS
0
2
4
6
8
10
Baseline
1 Month
3 Months
6 Months

SF-McGill questionnaire results

Total McGill score
0
5
10
15
20
25
30
35
Baseline
1 Month
3 Months
6 Months

Reduction in pain as recorded by a VAS score diary and SF-McGill questionnaire was significant and immediate. The reduction in pain stayed consistent throughout the 6 months study period.

Quality of Life Questionnaire: SF-36 Health Survey

0
10
20
30
40
50
60
70
80
Baseline
1 Month
3 Months
6 Months

The quality of life of subjects as measured by the SF-36 Health Survey increased from baseline by 15 points after the first month and stayed consistantly high.

BlueWind's Competitive Advantages

Simple, minimally  invasive procedure

Simple, minimally invasive procedure

Simple, minimally invasive procedure

BlueWind Medical’s neurostimulator is miniature and therefore the implantation procedure is simple

Battery-less

Battery-less

Battery-less

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

Targeted

Targeted

Targeted

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

Personalized

Personalized

Personalized

Treatment can be tailored to the needs of the patient. All state of the art features are available in one single device (Tonic, Burst and High-Frequency stimulation and more)

Leadless

Leadless

Leadless

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

MR safe

MR safe

MR safe

MR conditional for Static magnetic field of 1.5 and 3 Tesla

Closed loop mechanism

Closed loop mechanism

Closed loop mechanism

The BlueWind VIVENDI™ products have a closed loop mechanism which ensures consistent and dependable stimulation maintaining patient’s convenience in everyday activities