Very interesting. I do have A Salitron device and used it after radiation for a brief period and it did help with saliva production. Since I was also on Saligen, I did not have a very dry mouth but my saliva was very thick. The Salitron device stimated whatever nerves to the gland that produce the thin saliva so I was almost back to normal. I don't know if this is even made anymore and when Brian checked with MD Anderson a couple of years ago, they had not even heard of it. I don't know why the ariticle calls it a 'video device', mine wasn't nor was it something you carried around. You were supposed to use it 3 times a day for about 5 minutes for a month. This new gadget sounds like a great improvement.

Eileen

This link will work now. www.saliwell.com


It tried it and it worked for me.

Jerry

Jerry, in your future conversations with Mr. Wolff could you ask him where a person could go to get this device? I would really like to try it FDA approval or not.

Mark,

I have a feeling that he will say ....since it is not FDA approved yet, he can't doing anything for you at this point in time. However, I cannot speak for him. I am sure that he would welcome an email from you. I know he was anxious for the link to work so that our members could read about the Saliwell device.

Try : [email protected]. You can then post his answer here to avoid multiple contacts with him about the device.

Jerry

This may be the most exciting thing coming down the pike, short of a complete cure. I am one of lucky stage 4 survivors who can still spit quite nicely, but for everyone who cannot, what an incredible quality of life improvement this will be! Although I stay as far away from politicians as I can, this is one time when I wish I knew someone who could fast track this through the FDA.

Thank you very, very much, Jerry, for supplying much more than a glimmer of hope!

Indeed. That's a very hopeful-sounding little device. I hope you'll keep us up to date on when it will on the market or even coming up for a clinical trial we might be able to participate in (I too am taking salagen but getting a lot more thick saliva than thin saliva).

Nelie

It sounds like a good idea.

Here's the regulatory process. If it is deemed a "non-significant risk" (NSR) device then a letter to the hospital (or sometimes private independent clinical investigation contractors) for an internal "Investigational Device Exemption" (IDE), could get clearance to use it in a "beta testing" or clinical trial situation. This is done all the time at teaching and reseach hospitals (it would require prior approval by the "Institutional Review Board (IRB) at the facility. Since it is implantable and introduces energy into the body, it might be considered, by the FDA, to be a "Significant Risk Device" (SRD)(or converesly a new technological advance), in which case, an IDE would have to be filed to and cleared, by the FDA, prior to it's use on human subjects. Because it is an implant, patient contact material biocompatibility safety could also be an issue. I would imagaine the the manufacturer has already done that testing (ISO 10993). Similar devices like TENS units are considered "Class II" and require a 510(k) clearance to market. If this device has no existing predicate device in the market (i.e. a similar device with 510K clearance, then it could well be deemed a "class III" device, requiring a full blown Pre-Market Approval (PMA). This process is lengthly and can take a year or more. It is also very expensive.

"Fast Tracking" through the FDA is only allowed for devices that can have major, provable, life saving benefits. "Quality of life" devices typically to not fall into this category.

There are numerous other side issues - this is a foreign company and compliance issues differ in foreign countries. They would have to be in compliance with US FDA GMP/QSR (Good Manufacturing Practices/Quality System Regulation as well) and prior to the FDA acceptance of a IDE, if a PMA is indeed needed, they would have to request and pass a GMP/QSR audit/inspection by the FDA, at their manufacturing facility. Currently they are not listed in the FDA database as a medical device manufacturer for the US market.

If the device is, in fact, class II or III (which in my professional opinion would be) and it has no FDA clearance to market and/or they are not registered as a medical device manafacturer, then it is considered, by the FDA, to be an "adulterated, misbranded" product. It's use on human subjects here would be clearly illegal. Especially if there is no IDE on file. They would need an FDA approved IDE for clinical studies in the US. They would have to be a registered medical device manufacturer prior to submitting an IDE.

I am a regulatory professionl and just the messenger - so please don't debate me on this. This is ALL factual information and you can click on the link below and see for yourself. I just don't want to give false hope that this will become available simply by emailing to Israel and having them mail you one anytime soon.

Here is a link to the FDA describing, in more detail, the regulatory process for getting device cleared to market.
http://www.fda.gov/cdrh/devadvice/3122.html

Non regulatory issues would be that this device could well be damaged by radiation so it would have to be implanted after radiation, HBO would have to be part of the protocol.

But Gary, how about the version that is just an insertable, then take out again appliance? Not much different in appearance than sports teeth guards. This is the one that patients describe as using two or three times a day for just a few minutes.

Gary,

That sure was an eyeful. I'm sure no one will try to debate you on this. It's great to have someone with your background here to keep us informed about this, as well as all the other topics that you have such a great deal of knowledge about. I have reread your post several times and although I don't follow most of it, there is one question I have. One of the devices itself is not implantable, but is fabricated in a crown that is attached to the implant. As we all know, the implants themselves have FDA approval. So wouldn't this bypass the obstacle of "implantation"?

Joanna makes a good point about the mouth guard removable type device. This seems like it would be easy to get FDA approval, as it is non-invasive. I also think it is a more practical solution and one that will certainly be less expensive than having an implant placed. However, if someone has an implant already, that will lower the costs and they wouldn't need to take anything out on a daily basis. I'm sure anyone with xerostomia would certainly put up with a mouthguard type device, if they could get the saliva flowing.

I just went back and reread my emails from and to Dr. Wolff and what I read is that his company has needed additional funding in order to get through the process of getting FDA approval. Doesn't it always come down to money? In a May email he stated that they HAVE started the FDA process, so this is encouraging.

I intend to keep in touch with Dr. Wolff, however if anyone wants to contact the company directly, there is a "Contact Us" link on the website.

And Gary, congratulations on reaching your new milestone.

Jerry

It would still have to have an FDA APPROVAL. As someone who has taken over 50 class 3 medical devices through the FDA, I can assure you that Gary has this right. If a 510k approval were to be granted it could happen really fast, (I just helped a company that has a new discovery device get one.) The pre existing device had to exist in the US marketplace before 1972. It took us 4 months to get through. Anything more than a 510k could take years and never get approved after all that time in process. Much of a devices class designation has to do with how much risk it imposes on the person for which it use is intended, and the claims that you wish to make about it. For instance both the Vizilite and the Velscope are 510k approved devices. Do they find cancer? Yes. Can they make that claim? No. They have issues with specificity and therefore their claims are that they are general discovery devices and not diagnostic devices. If they step over the line in the marketing etc. they can have the approval revoked. As the previous owner of a class 3 medical device company, I can tell you that FDA protocols, GMP's and the like are one of the major expenses of operation of the company. I manufactured implants, and the paper trail from the purchase of the raw titanium to the inspection of the final product was monumental.

All that said, if someone was in process of FDA approval and they let you try one out, sold you one, etc. outside of their apaproval process, it would be a cold day in hell when the FDA every approved it if they found out.