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| 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. |
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#1
02-12-2007, 05:53 PM
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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?
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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 
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#2
02-12-2007, 05:55 PM
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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!
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"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
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#3
02-12-2007, 05:58 PM
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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.
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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
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