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Bryan cervical disc approved

This is a discussion on Bryan cervical disc approved within the Artificial Disc Replacement forums, part of the Spine Surgery Support category; FDA posted the info today. It was approved back on May 12. Good news for me as my surgery is ...

  1. #1
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    Default Bryan cervical disc approved

    FDA posted the info today. It was approved back on May 12. Good news for me as my surgery is scheduled for August 5 and I didn't want to delay it again.

    http://www.fda.gov/cdrh/mda/docs/P060023.html

  2. #2
    Founder / Administrator Justin's Avatar
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    Quote Originally Posted by RedStang View Post
    FDA posted the info today. It was approved back on May 12. Good news for me as my surgery is scheduled for August 5 and I didn't want to delay it again.

    http://www.fda.gov/cdrh/mda/docs/P060023.html
    Thanks RedStang! Good luck on August 5th!

    BTW, I've updated the FDA Approval Letters: Cervical & Lumbar Artificial Disc Replacement Devices thread in the Artificial Disc Replacement sub-forum to reflect this latest approval. (The thread is missing some information, but it will be posted shortly.)

    Justin Averna
    Founder & President, Spine Patient Society™
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    • 1994: Football Injury, Severe Hyperextension
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    • 11/15/2003: 2-Level ProDisc® L4/L5 & L5/L6*, *lumbosacral transitional vertebra --> Dr. Rudolf Bertagnoli
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    • 5/14/2009: Dynamic Stabilization System L4/L5, Dr. Rudolf Bertagnoli
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  3. #3
    Moderator Terry Newton's Avatar
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    I am thrilled that this disc got approved. I am eagerly awaiting the approval of the Maverick Disc as well. Another tool in the arsenal of spinal surgery.
    Terry Newton; Moderator

    1980 ruptured L4-L5
    1988 ruptured SI-L5
    1990 ruptured C5-C6
    1994 ruptured C6-C7
    1995 Hemi-Laminectomy surgery C5-C6, C6-C7 Mayo Clinic
    Bicycle Accident with a large dog in 2004
    Shoulder reconstruction surgery
    MRI, EMG, Facet Injections, Epidural Blocks, Lumbar Discogram.
    Stenum Hospital Surgery November 4, 2006
    Prestige Disc C5-C6, C6-C7
    Maverick Disc S1-L5, L4-L5

    I'm busy living my life after a successful 4-level ADR surgery with Dr. Ritter-Lang at Stenum Hospital in Germany. If you would like to contact me, please click the email icon under my SPS Member Profile, as I'm not on SPS daily.

  4. #4
    Super Moderator trkdoc714's Avatar
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    That's great news Jason!

    As for the Maverick, I got a reply from one of the inventors after I inquired about the FDA approval. The response was good in that the lawsuit (which will probably be appealed) by Synthes will only cost them 18% of the cost of the disc. They don't see any problems with this as it won't put it at a price disparity and plan to roll the disc out as soon as the FDA approves it. They also plan to file for trials of two level implantations.

    Bob
    04/06 L5/S1 Rupture
    05/06 MRI shows DDD @ L2-S1
    06/06 Diskectomy/ Laminotomy L5/S1
    04/07 Recurrent Disc L5/S1
    4 Ortho and 1 Neuro Surgeon, 5 MRIs, 1 EGM, 1 Myleogram & 11 EDIs later:
    03/27/09 L4/5 & L5/S1 Maverick discs at Stenum (www.dr-ritter-lang.com)
    11/9/11 C6/7 Herniation with Nerve Impingement. Another journey begins.

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