VNS Therapy (Vagus Nerve Stimulation): Neurotech ADNS-300 Vagus Nerve Stimulator

To the readership,

I was prompted to write to a company Neurotech after reading some comments recently posted to the VNSmessage Board:

“Hi and welcome to the forum.

Will this new device also attach to the Vagus nerve or is it going to been something more like NeuroPace's RNS system (direct brain stimulation)?

A rechargeable battery that lessens the need for additional surgeries to replace batteries sounds like a huge improvement. What issues will people face with battery memory and/or overcharging?

How does the electronic remote control work? How is it safeguarded against interference and/or hacking?” --- Bernard

http://www.vnsmessageboard.com/index.php/topic,4141.0.html

My recent collaboration with the company’s Vice President of Marketing & Business Development is listed below for your information. May I also suggest for informational purposes that the reader peruse Neurotech's website: http://www.neurotech.be/vpage.php?id=29&lg=4

Warmly,
Herb

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From: Herb
Date: Thu, Mar 1, 2012 at 2:47 AM
Subject: Vagus Nerve Stimulator
To: sales@neurotech-int.eu

To Whom It May Concern:

One of your representatives/employees is apparently posting to the message forum of www.vnsmessageboard.com. I find the information interesting but the fact remains your device is not FDA approved in the United States at the time of this communication.

Sometime in November 2010 a three patient trial was run utilizing your device. I’ve been unable to find additional information and/or trials. Has the EU given approval for the sale of your device and can you direct me toward additional information?

It would be useful if you would please explain when and if your company has filed with the FDA and when one might expect your device to be approved and available in the U.S.

To which I’ll also add that your response to Bernard while helpful to those who would have interest in this particular therapy, Bernard along with the site administrator and many participants to that particular forum are negative toward VNS Therapy and in the past have stated and called for the banning of VNS Therapy. In fact, had Bernard who in the past presumes himself to be knowledgeable of VNS Therapy only to be proven wrong, he would have already known the answers to several of his questions.

So please be aware of the hornet’s nest you’ve ventured into and don't give credit needlessly where it is not due.

Warmly,
Herb
vnsdepression@gmail.com
http://www.vnstherapy-herb.blogspot.com

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From: Peter Bergsma

Date: Thu, Mar 1, 2012 at 3:20 AM
Subject: RE: Vagus Nerve Stimulator
To: Herb

Dear Herb,

thank you for your open communication.

I confirm that one of my employees has been tasked to make information available on vnsmessageboard.com.

As was posted the device will become available this year in Europe due to our CE certification (and gradually in other countries accepting CE certification)

As our device has obtained an equivalence status ( similar to a 510k status in the US) to a predicate device (from Cyberonics) we are not required to perform any clinical trials to prove its efficacy.

We did indeed some implantations in Europe under an experimental protocol, but this has not been part of our CE certification.

Neurotech has not yet filed with the FDA, but will in the next 1-2 years (pending sufficient funding) and will be required to do a full clinical trial. The FDA apparently remains positive towards a competitor in a so far monopolistic market.

Although I understand your , and others, concerns about the vagus nerve therapy against epilepsy, I am optimistic that we can contribute towards an improved responder rate, using our innovative CAP sensing technology and improved electrode/lead. In addition we feel that the recharge technology provides an improved patient comfort and better return on investment. Time will tell.

In any case thanks for the head-up and success with your blog.

Best regards;

De : Herb [mailto:vnsdepression@gmail.com]
Envoyé : jeudi 1 mars 2012 8:47
À : Bergsma Peter
Objet : Vagus Nerve Stimulator

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From: Herb
Date: Thu, Mar 1, 2012 at 5:44 AM
Subject: Re: Vagus Nerve Stimulator
To: Peter Bergsma

Dear Peter,

Thank you for taking the time to respond.

As you may or may not have learned from my blog I've been a support person and health care advocate for my spouse Joyce approaching 5 decades. My experiences and reasonable knowledge relates to MDD (Major Depressive Disorder) as well as to VNS Therapy and its application for Depression. I do not give advice nor do I tell anyone what or what not to do but rather share our experiences and my knowledge as it relates to VNS. Joyce has celebrated this past December, 12 years of VNS Therapy. In her case the therapy has proven remarkable as we no longer have needed to discuss depression. Although, I also from time to time share my research and knowledge of VNS Therapy by participating on sites also related to Epilepsy.

With the above stated I would like to ask your permission to share our recent communications publicly to better educate those prospective patients and/or their support persons to newer alternative and adjunctive therapies?

Once again, thanks for the information and clarifications. It is much appreciated.

Warmly,
Herbert Stein
vnsdepression@gmail.com
http://www.vnstherapy-herb.blogspot.com

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From: Peter Bergsma
Date: Thu, Mar 1, 2012 at 6:13 AM
Subject: RE: Vagus Nerve Stimulator
To: Herb

Herb,

sure you can make the information available to others.

For your information, and others, we will apply for CE certification (based on equivalence with a predicate device=Cyberonics) for the Depression indication later this year and expect to be on the market in Europe with vagus nerve stimulation for depression some time in 2013. Although we have plans to enter the US market with epilepsy, for the moment we do not have any plan to do the same with the depression indication. Let’s see how the insurance companies react to the renewed efforts for reimbursement by Cyberonics.

May I ask you where in the world you live, as to understand your interest for either CE or FDA news?

Best regards;

Peter

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From: Herb
Date: Thu, Mar 1, 2012 at 1:52 PM
Subject: Re: Vagus Nerve Stimulator
To: Peter Bergsma

Peter,

I live in Weston, Florida which is one of the newest cities in the State of Florida. At one time it was part of Fort Lauderdale, FL when it became its own city in 1996.

In my retirement I continue my readings and research into therapies for depression with a particular keen eye on VNS Therapy as long as my spouse continues her use of that therapy. As well I also research and read with a keen interest into the newer neuromodulation therapies such as rTMS, DBS etc. During these past 5 decades I have collaborated throughout the world with many of the leading medical experts and a number corporate CEO's as it relates especially to VNS Therapy and I shall continue to do so as long as Joyce continues with the therapy. I try my best to be reasonably and factually informed and will respectfully telephone and/or communicate through any means with anyone willing to share needed information with me.

At one time I maintained a website entitled "VNSdepression.com" sharing information as well as my research, experiences, knowledge and thoughts as it related to VNS Therapy. On that site I also shared many of my collaborations with the permission of the medical practitioners, CEO's etc. to better inform the prospective patients and/or their support persons. With CMS (Centers for Medicare/Medicaid Services) denying approval for Depression treatment here in the U.S. I felt the number of patients to be implanted would be severely impacted by the considerable cost and lack of insurance reimbursement that my efforts directed to newer patients would be severely limited. I decided to close the website, save myself the expense and time of maintaining the site and in its place I still maintain a presence with a limited blog site to which I shall shortly add our correspondence as you agreed.

I am a very long-time vocal advocate for education while encouraging hope and persistence. At the same time I also encourage research into newer treatment options for Depression simply because if one follows the issues one learns many of the conventional treatment options for this unique and seriously ill population of patients have been either ineffective and/or inadequate.

This also brings up another important point which I would address at this time. I was at one time requested to moderate and participate on the very forum to which you've posted, the VNSMessage Board. I say "one time" as I opposed the dissemination of mis-information as well as the preponderance of biased opinions shared on that forum. I acknowledge the fact and share that with many therapies there are potentially serious side-effects and I certainly feel badly for those while trying to achieve some degree of wellness only encounter additional serious medical issues. What I didn't accept are those calling for the banning of VNS Therapy knowing full well there are many Epilepsy as well as Depression patients benefiting from the very same therapy. The site administrator of the VNSmessage Board chose to excommunicate me from her forum at which time I established the VNSdepression.com website. I used the VNSdepression.com site and forum for a number of years to factually inform and refute many of the inaccurate statements of the VNSmessage Board site administrator, her followers and Bernard as well by sharing research information and the factual statements of the practitioners, nuerosurgeons, CEO's etc. utilizing and affiliated with VNS. It seems anytime there was an opportunity to "bad mouth" the VNS Therapy the site administrator of the VNSmessage Board jumped on the opportunity to do so with little or no knowledge of what she had to speak about.

I've saved most all the data from my former website for occasions such as this and I've attached one piece of communication with one of your Europeon physicians, Dr. Rijkers, in a matter totally blown out of proportion and disseminated with mis-information on the VNSmessage Board. I'll leave it to you to research on that forum all the mis-information relating to this issue. I chose to contact the physician directly and obtain the facts in the matter to be better informed and to share with others. Worse yet and in my opinion what I consider to be reprehensible, the site administrator and participants of the VNSmessage Board read the posting(s) to my site and not one of them thought to communicate on their forum the correct information and hence my reasons to alert you to what you truly are dealing with on that particular message forum and website. Facts don't count there while the dissemination of misinformation is not only allowed and not corrected but rampant.

I think the above information kind of sums up who and what I am about and should more than adequately answer your questions.

I am for the advancement of therapies which originally alerted me to your product in the abstract I read back in November 2010. I make my best efforts to share a balanced perspective when reporting and/or sharing my thoughts. I appreciate having this dialog with you at this time knowing that both Epilepsy and Depression patients throughout the world will have an additional choice and at some point be coming due for pulse generator replacements. With this information and the patient collaborating with his/her respective physicians they all hopefully will become more knowledgeable of your product(s) as well as newer treatment options coming to market.

Warmly,

Herb
vnsdepression@gmail.com
http://www.vnstherapy-herb.blogspot.com

VNS Therapy (Vagus Nerve Stimulation)

Thursday, March 1, 2012

Neurotech ADNS-300 Vagus Nerve Stimulator

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