LINX Clinical Trials

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Chuck T
Regular Member


Date Joined May 2011
Total Posts : 143
   Posted 7/5/2011 12:05 PM (GMT -6)   
Anyone heard anything about the results of the clinical trials. I believe that the 3 year trial was scheduled to be complete in June. I am hoping that the results will fast track FDA approval. Looks like thier website is down, so there must be some rumblings (hopefully in a good way). Also, I remember hearing a couple of memebers on this board mentioning that they were scheduled for a LINX procedure in late June anyone heard from any of them, or Slicer? Thanks!
 
Chuck T

mock turtle
Regular Member


Date Joined Mar 2011
Total Posts : 467
   Posted 7/5/2011 2:09 PM (GMT -6)   
Yeah i remember 7 or 8 months ago hearing from a member named shooz...he had reported some problems and then improvement

and then shooz said that he was going to get back to us some more on how his lynx procedure was doing, but then he abruptly stopped commenting

and slicer, too...i saw where he was lurking on may 7th more than a week after his last post where he said he would give us an update...but no word since

there is a theory that those who have complications to surgery return for support more often than those who are getting on without a hitch....and i think that makes sense

as for the lynx trials i recall that october 2011 was when an announcement from the company and FDA is expected...but i believe you are correct the end of data collection was june...not sure on all this,... from memory

Chuck T
Regular Member


Date Joined May 2011
Total Posts : 143
   Posted 7/5/2011 2:21 PM (GMT -6)   
Wish we could speed these things along.

I think that Shooz's surgery was considered a failure as he developed an ulcer above the device, but if memory serves correct, he was able to get it cured with PPIs. I hope they are both doing well, because I think they both had LPR, and we LPR guys need something to look forward to.

Raj2011
Regular Member


Date Joined Mar 2011
Total Posts : 64
   Posted 7/5/2011 4:19 PM (GMT -6)   
In the last couple of days, i had an email correspondance with UC San Diego centre which is part of the trials :  Read from bottom ups
 

3. Not necessarily.  There is a potential that the FDA could approve the LINX device before then.  We would just continue to collect long-term follow-up data on the initial patients.  Unfortunately, I am unable to predict exactly when the FDA will approve the device, but we are hopeful that it would actually be sometime within the next few years.

 

Ok, thanks for your note.  That would mean that the FDA decision is atleast 3 years away, if not more.   Am I reading this correctly ?

 

2. The current trial is in its follow-up phase only.  Patients are currently around 2 years post-op and will be followed through 5 years post-op… so there are about another 3 years of follow-up to go for patients already on this study.

 

1. Torax, the company who manufactures the LINX device, is hoping that the additional follow-up data will help with FDA approval.  Unfortunately I am unable to predict when this device may be FDA-approved and available for use outside of a clinical trial.


AntZag
New Member


Date Joined May 2011
Total Posts : 11
   Posted 7/7/2011 8:43 AM (GMT -6)   
I had the Linx put in at the end of June. So far so good. No more reflux. I am encountering a bit of the "first bite dysphagia" that occurs as a matter of course as the device is gradually enclosed in tissue by the body but nothing I can't handle. Otherwise amazing. I am sleeping flat for the first time in years, eating whatever I want with no ill effects (I had chronic GERD with LES pressure of 4). Overall I am extremely happy so far.

Chuck T
Regular Member


Date Joined May 2011
Total Posts : 143
   Posted 7/7/2011 9:04 AM (GMT -6)   
AntZag

That is great news! Im sure everyonen on here would really appreciate if you would come back periodically and update us with your status. Were you able to learn any info from your docs on success rates, FDA approval, etc...

Thanks!

stkitt
Forum Moderator


Date Joined Apr 2007
Total Posts : 32602
   Posted 7/7/2011 9:29 AM (GMT -6)   
There is  a Part 1 and a Part 2 to the Linx thread - here you go:
 
 
http://www.healingwell.com/community/default.aspx?f=45&m=1646140



~~Kitt~~
Moderator: Anxiety/Panic, Osteoarthritis, GERD/Heartburn and Heart/Cardiovascular Disease.
www.healingwell.com

"If you can't change the world, change your world"

Raj2011
Regular Member


Date Joined Mar 2011
Total Posts : 64
   Posted 7/7/2011 9:42 AM (GMT -6)   
Hello AntZag,

Congratulations on your successful treatment with Linx. Would you be able to share more details on the this new device and surgery - where u had it done, how long it took and how was the recovery. Will be very appreciated by other members of this groups

Raj

AntZag
New Member


Date Joined May 2011
Total Posts : 11
   Posted 8/3/2011 7:37 AM (GMT -6)   
Hi Raj, thanks very much. I had mine done in Manchester UK end of June by Professor Favretti. I actually live in Kenya but went to the UK for the surgery. The procedure is quick and uncomplicated - less complicated than having a gastric band placed. Recovery is quick - you can eat a normal diet the same day. I ate 3 sandwiches and a cheesecake the evening of my procedure. The incisions in your stomach heal in 10 days to 2 weeks. You have to eat slowly with small bites chewed well. I am on week 6 now and have had some dysphagia (they warn you to expect it) during that time including some nasty episodes where things really got stuck, but you just push through it. It is much improved now and hardly ever happens any more. As Shooz mentions in anothe rpost, some foods cause more problems than others - bread is a bad one, pastry, chips/ fries etc. Have to really chew them down to liquid. Otherwise great. 

I am off PPIs - I was on them for 12 years twice a day by the end. Currently I am going through bad acid rebound (which can happen if you stop ppis after being on them for a while and can last up to 3 months apparantly due to high gastrin levels in your blood) and this results in a hot/burning feeling in my stomach but the acid isn't escaping through my LES anymore so doesn't bother my esophagus. I just have to eat frequently to keep the acid busy.

 

so far so good...


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