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Author Topic: Cyberonics unable to get partner for depression  (Read 8110 times)
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Bernard
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« on: October 02, 2008, 01:25:23 AM »

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Medical-device maker Cyberonics Inc said it could not get a partner for its brain stimulation treatment in the depression indication, sending its shares down as much as 10 percent.

In February, Cyberonics said it was seeking a partner to help its vagus nerve stimulation (VNS) therapy device gain acceptance from Medicare for reimbursement and maintain approval in the depression indication.
...
The two post-market clinical programs mandated by the U.S. Food and Drug Administration for the depression indication are expected to cost $3.5 million to $4 million for the second half of 2009.

In a statement on Wednesday, Cyberonics said it is evaluating alternative actions to maintain the current regulatory approval and will not begin another clinical study related to the depression indication without a partner.
...

Cyberonics unable to get partner for depression therapy
« Last Edit: October 02, 2008, 01:25:46 AM by Bernard » Logged

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Birdbomb
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« Reply #1 on: October 02, 2008, 03:55:35 AM »

At one time they had several offers placed before them.  Medtronics even bought a huge hunk of stock only to sell for a loss when they had their own troubles.

No one wants to touch this company with a 10 foot pole.

Speaks volumes, doesn't it?
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oreo
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« Reply #2 on: October 02, 2008, 05:50:29 AM »

You know what?  My brain hurts just reading that !@#%****.

Perhaps this thought has been offered before....why in the world would the FDA approve ANYTHING that Medicare/Medicaid won't cover...meaning most insurance companies won't cover?????   Why isn't it a part of the procedure for the FDA to get approval from Medicare/Medicaid before approving anything for marketing?

Does the left hand know what the right hand is doing?  Obviously NOT.

So, now even though the FDA has approved VNS for depression, Cyberonics has to find a business PARTNER to PROVE it is effective enough to gain Medicare/Medicaid approval.  Again...this hurts my head!

Why isn't the National Institutes of Health backing a study regarding efficacy?  NIH does list a current clinical trial Cyberonics is doing on their website, but when I emailed them asking why they would have anything to do with a company that was unethical both financially and medically, they wrote me back saying that I would have to contact the FDA.

NIH is #2 (after the FDA) in helping to decide what meds/procedures are safe and effective.

So, we have these governmental agencies with HUGE budgets whose purpose is to protect us....and you can't even get anyone to give you a straight answer.  What's new?
« Last Edit: October 02, 2008, 05:53:58 AM by oreo » Logged

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gel61820
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« Reply #3 on: October 02, 2008, 08:39:32 AM »

:Yeah That:

Amen, Sister!
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"Do not go where the path may lead, go instead where there is no path and leave a trail." Ralph Waldo Emerson

VNS implanted July 2007 for Epilepsy.  Activated August 2007.  No success, so VNS was turned off in August 2008 and COMPLETELY removed (including coils) on Nov 25, 2008.
Dispatch
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« Reply #4 on: October 09, 2008, 03:46:17 AM »

:Yeah That: and :Yeah That:

I read else where on the net that Johnson & Johnson was considering this, so they must have said no no as well.

Too bad the NIH acted that way to you Oreo.  I think that answer was evading the question.  Call the FDA, like yeah right...they will tell you to send a letter to them, then you'll get an email or a letter back saying they're looking into it.

Not everyone who is suffering with depression is on Medicare, but a very large portion of people are because it is disabling.  But since Medicare won't cover this for depression neither will private insurers, so many thousands of people are left in the dust.  Either they have to fight with their private insurer to get implanted OR they have to fight for payment and continued care after implant.  That has got to create worse depression, especially when Cyberonics is famous for telling patients this is their last hope AND they'll help you get it covered.  I don't recall reading they have helped many people with the denials after implant or explant.  I had to do all mine by myself.

Dispatch B)
« Last Edit: October 09, 2008, 03:51:55 AM by Dispatch » Logged

VNS for TRD implant November, 2006.  Complete device removal including coils April, 2008.

"I reckon it's again my turn to win some or learn some..." Jason Mraz

ALL MY POSTINGS ON THE VNS MESSAGE BOARD ARE NON-TRANSFERABLE
labrat
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« Reply #5 on: October 09, 2008, 04:31:23 AM »

Let's not forget that it has been a God send to me for three years now.
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oreo
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« Reply #6 on: October 09, 2008, 08:12:08 AM »

Hi LabRat,

It's a great thing when someone gets relief from the horror of depression.  I am so thankful that you and certainly others we have not heard from have had such a great response to VNS.

I've also heard you say that you wish others could have the same outcome you have had.  I know your kind spirit wishes the best for everyone.

I am grateful for the benefits I have received due to VNS...I'm nowhere close to remission, but I'm certainly functional and as I've said, I do have times that are pretty good.  

It's so frustrating because the stress of the $64,000+ hanging over my head tends to threaten my health and well-being...also the knowledge that I've spent over 18 months jumping thru the hoops required by my insurance company and still have no promise they will pay the bills or cover me in the future for my VNS related services.

It's hard knowing that I did everything prior to my implant that I was required to do AND more...and the contract with insurance does not permit me to file suit until I've completed all their ridiculous appeals and outside reviews.  So, finally, I think that is done...  I don't think it's envy... but knowing that you've had three surgeries covered by insurance...I guess I am sad sometimes knowing it can be done...why not for me?

Ah well...poor me...my time will certainly come.  I am so fortunate LabRat to know you...to know that wonderful results are possible...and that in fact ethical insurance companies do honor their commitments!!!!!!!!

Keep reminding us that good things happen!
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labrat
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« Reply #7 on: October 09, 2008, 10:32:51 AM »

You got it! Hang in there, it will all work out, look at Bonnie's case!! :rolleyes:  
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gel61820
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« Reply #8 on: October 09, 2008, 05:52:07 PM »

Psssssssssst Labrat... over here>>>>>>>>>>     :bigarmhug:

You are absolutely right, it has been a God send for you and I am so thankful that it has.  You are the shining example of a person who could be the poster child for VNS in regards to depression.  With your personality and kind heart, you always see the good in things.  I am so very happy for you!

And by the way... how is the family visit thus far?  :usflag:

Hugs,
Cindy
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"Do not go where the path may lead, go instead where there is no path and leave a trail." Ralph Waldo Emerson

VNS implanted July 2007 for Epilepsy.  Activated August 2007.  No success, so VNS was turned off in August 2008 and COMPLETELY removed (including coils) on Nov 25, 2008.
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« Reply #9 on: October 10, 2008, 03:41:50 PM »

:D HEY Labrat!

I am glad it has been so wonderful for you, and happy to share in the good with ya!.  I too wish more success stories would be members.  Always remember though that it just wasn't the VNS that helped you...you were a major player in getting yourself well, so bunches of credit to you for all your hard work!! :bigarmhug:

 :hiya: Oreo!  I am also very happy for you that you have had some positive response to VNS.  I wish you had total remission, but considering all that is on your plate, it is amazing you aren't 50 steps backwards and in a deep depression.  You keep up the great work!!  :bigarmhug:

I am so proud of both you Ladies!  You are great examples of inspiration!

Dispatch B)
« Last Edit: October 10, 2008, 03:45:33 PM by Dispatch » Logged

VNS for TRD implant November, 2006.  Complete device removal including coils April, 2008.

"I reckon it's again my turn to win some or learn some..." Jason Mraz

ALL MY POSTINGS ON THE VNS MESSAGE BOARD ARE NON-TRANSFERABLE
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