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Good news for LINX FDA panel date

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Posted 11/22/2011 12:49 AM (GMT 0)
In January 11, 2012...the FDA panel will vote on LINX to be approved in the US....if that's what I understand from the article. Please share your thoughts...I for one is still suffering from lpr and gastritis but can't wait for this one to knock at least half of my problems down....

http://www.google.com/url?sa=t&rct=j&q=torax%20linx%20fda&source=web&cd=11&ved=0CCoQFjAAOAo&url=http%3A%2F%2Fwww.fda.gov%2FAdvisoryCommittees%2FCalendar%2Fucm280285.htm&ei=Ue_KTvr3I4r8iQLc0qy-Cw&usg=AFQjCNEDZrpmrcvOm3M-ICLCEHEntkoWIA&sig2=g8h5YGE5XCRZOqIeO8pVdw


http://www.google.com/url?sa=t&rct=j&q=linx%20fda%20panel&source=web&cd=6&ved=0CFQQFjAF&url=http%3A%2F%2Fwww.massdevice.com%2Fnews%2Fjjs-ethicon-endo-surgery-gets-appeal-date-sedasys-denial&ei=fPHKToqGLIOZiQK32pDBCw&usg=AFQjCNEEDr0jdSlZNLkEnwepVjXXJ2ngoA&sig2=G1C-WfZ_gbakvKb_8Kc6Aw
Posted 11/22/2011 12:59 AM (GMT 0)
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm280285.htm#.Tsr0X9K536c.mailto
Posted 11/22/2011 12:59 AM (GMT 0)
I don't know how to link this ....
Posted 11/22/2011 1:13 AM (GMT 0)
Thanks Maximus .. looks like this is going to be quite important to some of us ..

Here is the clickable link ..

www.fda.gov/AdvisoryCommittees/Calendar/ucm280285.htm
Posted 11/22/2011 1:17 AM (GMT 0)
Yes, i actually have an appointment with a surgeon on Dec 1 to discuss NF. But I'd rather wait for this. My symptoms are atypical. No real heartburn but constant throat tightness, sore throat, burning tongue etc....symptoms of LPR...that PPIs do not help. I currently take H2 blockers but more for gastritis....
Posted 11/22/2011 1:21 AM (GMT 0)
If the committee approves this, I wonder how long before it gets to mainstream so we can have it implanted. I live in Hawaii so I wonder where would be best to have this done? Posssiblr USC? Or one of Califiornia locations
Posted 11/22/2011 11:26 PM (GMT 0)
if, and more likely, when this gets approved...there is going to be a line around the block...no check that, a line around the country waiting for a turn to get the procedure
Posted 11/22/2011 11:58 PM (GMT 0)
I wonder where would be the first locations to offer them
Posted 11/23/2011 12:14 AM (GMT 0)
I would think the hospitals that were involved with the clinical trials will probably want to use that
experience and be able to offer them right away - that is just my guess though. It is only when the
insurance companies start covering this procedure - that we'll see larger number of patients
starting to use this to address the heartburn.
Posted 11/23/2011 12:30 AM (GMT 0)
I wonder how much would it be without insurance?
Posted 1/11/2012 6:08 PM (GMT 0)
bumping this thread ... as this meeting should be happening today. Hopefully, we'll hear about this sometime later today ...
Posted 1/12/2012 12:09 AM (GMT 0)
Found these two documents on fda.gov's site that might shed some more light on what possibly got reviewed and discussed today at the advisory committee meeting:

www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM286238.pdf

www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM286236.pdf
Posted 1/12/2012 12:25 AM (GMT 0)

This is a long and interesting readying - looks like the results of the last 2-3 years of clinical trials.    This document was prepared by TORAX, makers of LINX.   I am so curious to see what will FDA decide, and when will they decide.   Keeping my fingers crossed

Raj

Posted 1/12/2012 4:17 AM (GMT 0)
This link says the panel endorses approval:

http://www.medscape.com/viewarticle/756787
Posted 1/12/2012 5:02 AM (GMT 0)
Fascinating stuff - thanks for posting all the updates! The second PDF you posted PPI-LESS is particularly interesting as it covers all kinds of GERD related topics and treatment options.

Does anyone know what Linx being granted "Pre Market Approval" means exactly? Does it mean that they can start marketing the device to surgeons and that people can start using it as an option? Or is it another less restricted trial and research period that only a few select people can apply to?
Posted 1/12/2012 7:05 AM (GMT 0)
wow!

regarding the FDA panels unanimous vote in favor of torax linx today,

"Drew B. Schembre, MD, from the Swedish Gastroenterology, Swedish Medical Group, in Seattle, Washington, said, "It was nice to finally see a device study where objective criteria were used and actually showed a change in physiology, and that correlated well with the quality of life symptom data. That, plus the surprising and singular lack of significant long term side effects, at least at 2 years, was convincing for me.""

google

linx reflux management system scores a hat trick

and click on first hit...or

or

copy and paste this address into your url window and you will be able to read the entire article

http://www.google.com/url?sa=t&rct=j&q=panel%20recommends%20approval%20torax%20linx&source=web&cd=1&sqi=2&ved=0CCAQFjAA&url=http%3A%2F%2Fwww.medscape.com%2Fviewarticle%2F756787&ei=iYEOT7aVDuLgiAKfq5SuDQ&usg=AFQjCNEKlQOxqkFvC7-eI43jB8AXET_K3w&cad=rja

very best wishes
mock turtle
Posted 1/12/2012 4:04 PM (GMT 0)
Premarket approval =  a scientific review to ensure the device's safety
Posted 1/12/2012 4:19 PM (GMT 0)
So, does it mean more/new trials?
Posted 1/12/2012 4:37 PM (GMT 0)
Based on my little understanding of how the process works it probably will take another year until the FDA will approve it for the market.  The approval yesterday does not guarantee a full approval from the FDA but it is a good step forward.
Posted 1/17/2012 1:46 AM (GMT 0)
From Torax medical's site:

www.toraxmedical.com/news/downloads/PR_Torax_LinxFDA_AdvisoryPanel.pdf
Posted 1/22/2012 8:21 PM (GMT 0)
Does anyone know how long it takes the FDA to approve a medical device on average once it receives approval from the sub-committee.
Posted 1/22/2012 8:44 PM (GMT 0)

Surgeons at The Ohio State University Medical Center are currently participating in a clinic

research study examining an investigational procedure that might help reduce or eliminate

acid reflux symptoms. From their website:

We are currently screening interested patients for participation in the LINX Reflux Management

System clinical trial. If you have questions about this study, please contact

Rebecca Dettorre, CCRC, at (614)-293-8549.

I am not sure how current this data is.

Kitt

Posted 1/30/2012 12:20 AM (GMT 0)
stkitt, I contacted OSU and that study was one of the original trials and is no longer active. One would think they would remove that data from their website.....
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