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Linx system surgery Part 3 of 3

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Posted 2/12/2011 10:44 PM (GMT 0)
Sorry for bringing up the topic again...but I am very very interested in this procedure. Do you know what phase of the approval process is the procedure under at the moment, and how long does it take for it to get approved?

If there are still some phases to go and they need more people for trials, I think I would like to participate in the trial =)
Posted 2/13/2011 9:48 PM (GMT 0)
Are you in the UK or US Usagihime?
Posted 2/14/2011 2:23 AM (GMT 0)
I'm actually in Canada ^^; But I would go to the US to do the surgery...but I guess you have to be a US Citizen to participate in trials?
Posted 2/14/2011 5:56 PM (GMT 0)
Think you would be, and I don't think they have trials on Linx any more in US, I may be wrong. They are just waiting for approval to use in mainstream. I will try and find out why it is taking longer in the US than it is in europe. Thought it was normally the other way around. So you've looked at other options and think LINX is the way to go?
What tests have you had, and how bad are your symptoms?

Regards,

Lewis.
Posted 2/14/2011 11:55 PM (GMT 0)
My symptoms are being controlled for the moment with Nexium, and I am a newly diagnosed GERD patient, right now with no damages from the acid yet. My GERD is due to a transient LES and possibly IBS-C. For now I only had an a Barium Swallow 2 months ago when heartburn first started surfacing which shows no signs of reflux (but my symptoms have gotten worse since then), as well as an endoscopy 3 days ago which showed the slightly open LES. Ohh and I also had an abdomen ultrasound which ruled out gallbladder problems. Currently waiting for biopsy results for H Pylori and gastritis. The GI did not mention any hiatal hernia after the endoscopy so I assume I don't have one.

I just thought that Linx would be a good fix before there is any true damage, as I do not want to be on Nexium long term! =)
Posted 5/5/2011 1:25 PM (GMT 0)
I've been watching these developments with interest as well. I can not tolerate any PPIs or H2s (really bad side effects).

So, I was wondering if this could be something that I can get done. My symptoms currently are: nausea, throat itchiness and slight dysphagia that I am controlling with diet, supplements and acupuncture.

Do you think I'll still qualify even if I can not tolerate the meds? I've heard that some patients may have to be on the meds even after this procedure for some time - which would mean I (and others like me) can not qualify?
Posted 6/8/2011 10:17 AM (GMT 0)
I haven't heard from folks here in some time .. shooz how are you doing with the device?

One of my questions is - if the LPR is not that severe - but is causing quality of life issues though .. such as weak voice etc., then will this device still be able to hold back "all" backflow of the acid? Or, some acid will still trickle up to the throat?

So, the question is - how good is the linx device to arrest all acid backflow when the transient LES relaxations occur? Can it completely control such flow and therefore will heal the throat and make us completely LPR "symptom free" - or will it only "reduce" the symptoms?
Posted 6/8/2011 11:31 AM (GMT 0)
Shooz,

I am having the Linx put in on June 26th and was very keen to hear how you are getting on. Did you have the "First bite" dysphagia for a few weeks after implantation? I believe it only lasts a short while (as the new tissue forms around it) and then goes away and you can eat relatively normally. Was this the case with you? Can you eat most things now? Do you have any other issues with it at all?
Posted 6/10/2011 11:47 AM (GMT 0)
Yes, specifically I am interested to know about these "spasms/pains" that shooz has mentioned in some other thread here .. and wolfz wanted to take it out because of that.
Posted 6/16/2011 1:30 PM (GMT 0)
bump
Posted 6/20/2011 9:47 AM (GMT 0)
Lewis,
How are you feeling after the Torax surgery.
Has it cured your reflux?
Any side effects?
Regards,
Dev.
Posted 6/20/2011 11:42 PM (GMT 0)
We all want to know! I just hope he is doing so great he has even forgotten that he has the device and forgotten about this forum! haha

Hope he gets in touch with us!
Posted 9/16/2011 2:27 AM (GMT 0)
Can someone living in us get the linx overseas? What tests are needed to qualify. Meds are not helping me....had gerd for about 3 months really bad...thanks guys
Posted 9/17/2011 6:20 PM (GMT 0)
Iam getting a little nervous about the Torax procedure, as someone who was nearly tempted to spend £6000 having the operation performed in the U K.
My reason being that we are not getting much positive feed back recently.
I ask anyone who has had this proceedure.
What difference has it made to your life?
Are you symptom free?
Do you still take PPIs?
Posted 9/17/2011 6:30 PM (GMT 0)
Bloodaxe - why do you think the feedback is not positive?

Beargirl, Shooz and Lewis seem to be doing well after the implant - at least as far their reflux goes. Antzag was doing well too but then did say that the got some symptoms back but was thinking was because of the rebound from stopping the PPIs possibly.
Posted 9/17/2011 7:05 PM (GMT 0)
Can someone in the US fly overseas to get it?
Posted 9/17/2011 8:30 PM (GMT 0)
Folks at healthierweight (the clinic that offers LINX in the UK) have said that they can not offer or promote this to the US citizens because it would be against the FDA guidelines (since FDA has not approved it in the US yet).
Posted 9/17/2011 8:46 PM (GMT 0)
That's a bummer....I wonder when the FDA will approve it?
Posted 9/17/2011 9:12 PM (GMT 0)
There were 3 trials done (see below their details including the dates). I am hoping that at least after the final date of the 3rd trial (Feb 2012), FDA could take a decision on this. But, there is no such guarantee that they would take this / such a decision immediately after Feb 2012.

  • NCT01058564: “A Prospective Evaluation of the Torax Medical Inc. Magnetic Esophageal Sphincter”
    Single group assignment
    “To evaluate a novel method of augmenting a weak LES with a magnetic esophageal sphincter device”
    Prospective performance evaluation of the magnetic esophageal sphincter.
    Phase: I - II
    Number of patients: 4
    Start and completion: May 2008 Oct 2011

  • NCT01058070: “An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter”
    Single group assignment
    “To collect preliminary performance and safety information and develop procedural optimization for the Torax Medical Inc. MES device in reinforcement of Esophageal Sphincter function to treat GERD. The information from this study will be used to support the design and conduct of an expanded clinical trial”
    To evaluate the incidence of all adverse events at various time points.
    Phase: I - II
    Number of patients: 14
    Start and completion Feb 2007 Feb 2012

  • NCT01057992: “A Prospective Evaluation of the Torax Medical Inc. Magnetic Esophageal Sphincter”
    Single group assignment
    “To evaluate a novel method of augmenting a weak LES with a magnetic esophageal sphincter device”
    Prospective performance evaluation of the magnetic esophageal sphincter
    Phase: I - II
    Number of patients: 31
    Start and completion: Mar 2007 Feb 2012
Posted 9/17/2011 9:18 PM (GMT 0)
Is February 2012...the earliest then? I'm in so much pain with no relief fr
Meds :(
Posted 9/17/2011 9:22 PM (GMT 0)
Wasnt the stretta approved fairly quicky through FDA? Also, they have a website back up now from a new company. Did anyone look into this procedure?
Posted 9/17/2011 9:35 PM (GMT 0)
Re: Feb 2012 - I don't quite know, I am just taking a guess based on this public information.

I am on a similar boat as you - meds work for me but I can not be on them as they give severe side effects. I am trying to manage my symptoms with diet and supplements.

Some of the supplements that I take / have taken / plan to take are:
- DGL, Aloe-Vera (Georges), Marshmallow, Slippery Elm, Burdock, AcidGone,
- melatonin
- d-limonene
- Basil (tukmaria) seeds, Katira Gum
- Lions Mane Mushroom, ALA, EPO (these target the nervous system) - so I am hoping that if vagus nerve is causing my LES to relax, then if I treat the nerves, it can get better).

Post Edited (PPI-LESS) : 9/17/2011 3:39:37 PM (GMT-6)

Posted 9/17/2011 9:48 PM (GMT 0)
I hope my doctors can all get on board and see how much pain i am in and give me the ok for surgery even if it helps just a little it will be worth it...I love this forum and you guys as I know I am not alone. You all will become
My new friends ;)
Posted 10/10/2011 12:02 AM (GMT 0)
Hello Everyone..
I live in the USA, but am a frequent visitor to the UK and London in particular. As likely everyone knows, the Linx Magnetic ring is not yet approved for use in the USA. I have been told that I need the Nissen Gerd Surgery, but I have been watching the Linx progress now for about a year. I am thinking that Linx is at least as effective as the Nissen surgery and, if needed, the Linx can be easily removed and followed by the Nissen procedure.

Can someone tell me of Clinics/Hospitals in the London area that have the best specialists in the Linx installation? I am going to the UK in November for a few days and am thinking of taking my various test data with me and setting up a Clinic interview.

Thanks for your suggestions.
Posted 10/10/2011 12:41 AM (GMT 0)
Clinics in England are refusing to promote or offer this procedure to the US citizens since it is not approved by the FDA here yet. You can contact linxrefluxsurgery.com but that is what they told me.

Linx is reversible .. but remember that one has to go through the same surgery to take it out .. so it is not as simple as that ...
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