dma;Thanks for your response. Please refer to the message above,...

dma;

Thanks for your response. Please refer to the message above, this is the site I am having problem opening;
http://www.ausindustry.gov.au/library/CommercialReadyGrantAgreementssignedin06_07Dec_Jan_0720070228023007.pdf
As you have stated, is the site containing information on the Commercially ready Grant application for VCR to use TETS technology for its Ventrassist.

This site
http://www.newsrx.com/cgi-bin/samplepdf.cgi?filename=dc.pdf
acknowledged, is a rather large document, and I have been able to open it. I can also see where the Ventracor info is etc etc.

All I am saying is that I follow your reasoning. I just can't verify it because I unable to open the 1st document.

Based on what you have stated thus far, my thoughts are;
- If there is a move by vcr to introduce TETS tech. to the Ventrassist device, for it to have a commercial impact, it must be incorporated into the current trials. ie. the planned implant for BTT, DT and if possible BRACE should incorporate (be powered by) this technology.

- If this is what they are trying to do, by seeking approval from the TGA for TETS to be commercially used, this is fine, but there has to be something at the US and if applicable the EU side. IMO only, this may be regarded as an alteration to the device and that, may require some sort of a separate approval from FDA.

The key question is, does TETS require a separate approval from FDA to be included in the current BTT & DT trial???...if this is the case, then TGA alone is not enough.

If no separate approval is required from the FDA, ie. they (vcr) can convert the current devices to be powered by TETS and use them to power the devices for BTT and DT, THIS WOULD BE GREAT NEWS. Because of the benefits it provides the patient. Mind you, I believe they may still need to carry a single battery pack, as a backup (not as per the current 2 batteries)!!!!

IMO only, NOT incorporating TETS into the current trials, will be viewed by the market as another technology that needs to be trialed. And at this stage, it's about commercialisation not technology advancement.

I hope this has been helpful.

Thank you for digging this info. You're a heck of a digger dma, and you are good at it!!!!!...and I mean that in the sincerest way.

Cheer mate.