LINX Clinical Trials

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

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

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!

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