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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report. |
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