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Summary of the In Vivo Report
In vivo 19: 949-958 (2005)
Biological Effects of a Software-controlled Voltage Pulse Generator (PBK-2C) on the Release of Vascular Endothelial Growth Factor (VEGF)

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Background

VEGF : - Vascular Endothelial Growth Factor
A cytokine which has a variety of actions in the clotting of blood and in controlling blood pressure - it can be used as treatment to treat diseases such as heart attack and stroke i.e. areas of ischaemia.

Possible disadvantages
Pro-inflammatory side-effects (immune reactions)

VEGF can promote angiogenesis (the development of new blood vessels) - important in areas that are blocked i.e. the heart or the brain etc. Therefore electrical stimulation can locally up-regulate VEGF, previously demonstrated in the rat model on hind limb ischaemia (when an organ like the heart or brain does not receive enough oxygen thru the blood).

Aim of Study
Does a newly developed medical device which allows the amplification of electrical impulses result in VEGF production and angiogenesis in patients with PVD (peripheral vascular disease in blocked organs)?

Method
Nine people with blocked arteries due to ulcers participated in this study. They underwent an electrical stimulation session delivered by the PBK-2C for 20 minutes. Venous blood was drawn (before, during and after the session) for analysis of blood cell counts.

Results
No indication of adverse effects i.e. blood clotting or inflammation.
Both serum and plasma showed an increase in VEGF accompanied by an increase in TNFa and ILß only.
Circulating Nitric Oxide levels increased.

Observations based on the results
There is only a transient increase in inflammation (which is good) as this reduces to baseline. Also nitric oxide production is good!!

Conclusion
This study proved that the PBK System works on a molecular level by stimulating the release of a range of endogenous activators within various tissues. Most importantly, the localised release of VEGF has been clearly demonstrated in the laboratory - the PBK system is the only device currently available capable of stimulating this process. The results of this study were presented to the CE test board as part of the approval process. Current directives stipulate that scientific evidence must back-up clinical data to satisfy the CE mark requirements. Through this study the PBK System demonstrated the scientific basis of the clinical claims with ease.

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