ADRSupport Community  

Go Back   ADRSupport Community > General Discussion > The Big File

The Big File All issues not easily categorized in the above forums are here. Comments on general health, diet, "getting comfortable," and more are here.


Reply
 
Thread Tools
  #1  
Old 02-12-2007, 05:53 PM
LBP LBP is offline
Senior Member
 
Join Date: Aug 2005
Posts: 446
Default

Harrison thanks for posting the news article about Dr. Garcia in FL implanting an ActivL to kick off the new ActivL clinical trial. This is great news even if it's still only for 1 level..still a step in the right direction.

Just wondering...for those of you who have been through the Charite, ProDisc and Kineflex FDA trials...anyone know whether there is any possiblity that a single level FDA trial can make exceptions for 2 level candidates to get a 2 level activL? There was some lingo for people in prior trials like "compassionate use" etc...to make certain kinds of exceptions...anyone know what lingo to use to make something happen and who do you approach...the surgeon, the FDA, or the manufacturer?
__________________
Injured 9/01
Annular tears L4/5 & L5/S1
denied adr by insurance for 2 level charite as well as hybrid fusion at L5/S1 with Charite at L4/5.

New ins paid for 2 level lumbar prodisc surgery on 4/7/08 (at age 39) with Dr. Westerlund, at Core Orthop
Reply With Quote
  #2  
Old 02-12-2007, 05:55 PM
Harrison's Avatar
Harrison Harrison is offline
Administrator
 
Join Date: Oct 2004
Posts: 7,014
Default

LBP, many folks have had "off label" multiple level procedures under the compassionate use clause under FDA guidelines. I hope this practice will continue, time will tell...

Thank you to all of the people across many different organizations for allowing patients to receive disc replacements with this permission -- it has touched hundreds and hundreds of lives!
__________________
"Harrison" - info (at) adrsupport.org
Fell on my ***winter 2003, Canceled fusion April 6 2004
Reborn June 25th, 2004, L5-S1 ADR Charite in Boston
Founder & moderator of ADRSupport - 2004
Founder Arthroplasty Patient Foundation a 501(c)(3) - 2006
Creator & producer, Why Am I Still Sick? - 2012
Donate www.arthropatient.org/about/donate
Reply With Quote
  #3  
Old 02-12-2007, 05:58 PM
LBP LBP is offline
Senior Member
 
Join Date: Aug 2005
Posts: 446
Default

Did the "compassionate use" for multi level candidates happen in the beginning or middle of the fda trials? And how did that get initiated? When using the term "off label" I think of AFTER FDA approval, not during the trial. Can you clarify.
__________________
Injured 9/01
Annular tears L4/5 & L5/S1
denied adr by insurance for 2 level charite as well as hybrid fusion at L5/S1 with Charite at L4/5.

New ins paid for 2 level lumbar prodisc surgery on 4/7/08 (at age 39) with Dr. Westerlund, at Core Orthop
Reply With Quote
Reply

Bookmarks

Tags
activl clinical trial, compassionate use

Thread Tools

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Threads
Thread Thread Starter Forum Replies Last Post
Wallis vs ADR trial LBP The Big File 12 07-02-2008 05:55 PM


All times are GMT -4. The time now is 07:35 AM.


© Copyright 2006-2023 ADRSupport.org All rights reserved.