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| Arthroplasty Central Discuss Bryan Cervical ADR Approved by FDA 5/13/09 in the General Discussion forums; Hi, Decided to make a new post...finally have something to say! According to a recent e-mail from Jane Anderson at ... |
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#1
05-15-2009, 07:21 AM
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Bryan Cervical ADR Approved by FDA 5/13/09
Hi,
Decided to make a new post...finally have something to say! According to a recent e-mail from Jane Anderson at Medtronic, the Bryan Cervical ADR received final FDA approval on 5/13/09. I've been keeping tabs on the Bryan as a possible solution to address my herniated c6/c7 level. One reason I've been following this disc is that it's the only FDA approved disc that is MRI friendly. Question: Any thoughts on which surgeon would have the most experience with the Bryan? Thanks!     
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#2
05-27-2009, 09:10 PM
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Quote:
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DDD C5/6. Incorrectly diagnosed as tension headaches in September 1997. Nearly continuous headache since. Began having pain in wrists in 2000, believed it was onset of carpal tunnel. In 2005 pain began getting worse. Diagnosed as DDD in July 2007. Surgery recommended after 6weeks of PT made the pain worse. ADR scheduled for Jan 26, 2009. Rescheduled for August 5! Bryan disc finally FDA approved, and just in time too. Neck was all jacked up and had to be fused unfortunately.
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#3
05-27-2009, 09:17 PM
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Geo,
All artificial discs are MRI-friendly. Meaning, we patients can get an MRI without blowing up the machines or our innards! For what it's worth, iron and other ferrous materials are the issue; of course, some other metals can be a problem too. But the ADR mfr's figured this out in the 80s and 90s....I'll defer to the resident material scientists and radiologist (who are docs and patients) on this one. And what do you mean about the email from Medtronic? There's no public statement on this, as far as I can tell. Happy to be wrong, on this, of course. I looked for the public release last week and the one before. Can you post a link? Thanks! 
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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
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#4
05-27-2009, 09:42 PM
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__________________
DDD C5/6. Incorrectly diagnosed as tension headaches in September 1997. Nearly continuous headache since. Began having pain in wrists in 2000, believed it was onset of carpal tunnel. In 2005 pain began getting worse. Diagnosed as DDD in July 2007. Surgery recommended after 6weeks of PT made the pain worse. ADR scheduled for Jan 26, 2009. Rescheduled for August 5! Bryan disc finally FDA approved, and just in time too. Neck was all jacked up and had to be fused unfortunately.
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#5
05-28-2009, 02:01 AM
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new prodisc nova
I have heard of the new prodisc nova which is also supposed to be MRI friendly. I am not sure if there is an FDA trial or if they will have to do a new trial to approve the design change. As I understand, it is also titanium and polyurethane.
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Jessica 39 yrs old 10/2005 MVA C5-C6 herniation w/ cord impingement/displacement Unable to work full time. July 31, 2006 Surgery successfully completed Prodisc-C C5/C6 on in Straubing, Germany by Dr. Bertagnoli. Able to work full time since 1 month post op, but some pain remains. 10/2008 3 surgeons confirm C6/C7 needs ADR and always has. Has anyone had a second ADR surgery on an adjacent level?
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#6
05-28-2009, 11:13 AM
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Thanks Jason...
...for the links to the FDA site! The other links from there offer some meaty information:
IMPORTANT INFORMATION ON THE BRYAN® CERVICAL DISC http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060023c.pdf Jessica, you may already know that a few people here have the Nova disc, check out the post-op forum.
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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
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#7
05-28-2009, 11:15 AM
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Quote:
__________________
DDD C5/6. Incorrectly diagnosed as tension headaches in September 1997. Nearly continuous headache since. Began having pain in wrists in 2000, believed it was onset of carpal tunnel. In 2005 pain began getting worse. Diagnosed as DDD in July 2007. Surgery recommended after 6weeks of PT made the pain worse. ADR scheduled for Jan 26, 2009. Rescheduled for August 5! Bryan disc finally FDA approved, and just in time too. Neck was all jacked up and had to be fused unfortunately.
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