+ Reply to Thread
Page 1 of 2 1 2 LastLast
Results 1 to 10 of 14

M6-L (lumbar) Artificial Disc Replacement Available in Europe

This is a discussion on M6-L (lumbar) Artificial Disc Replacement Available in Europe within the Artificial Disc Replacement forums, part of the Spine Surgery Support category; Hello all. I just learned that Spinal Kinetics lumar version of the famous M6-C disc -- the M6-L -- is ...

  1. #1
    Senior Member Marti in Benicia's Avatar
    Join Date
    Jun 2009
    Location
    Benicia, CA (near San Francisco)
    Posts
    15
    Blog Entries
    1

    Default M6-L (lumbar) Artificial Disc Replacement Available in Europe

    Hello all. I just learned that Spinal Kinetics lumar version of the famous M6-C disc -- the M6-L -- is now approved and commercially available in Europe. They have over 1,000 in patients with excellent success.

    The very first one was implanted by Dr. Nick Boeree in Eastleigh, Southampton (UK). I have names of 3 other surgeons with M6-L experience, too.

    FYI -- The M6-L will not be available in the US; you have to go out-of-country to get it/them.

    No, I don't work for the manufacturer. I've had so much success with my two M6-C discs that I want others to know about the lumbar version. (Marti@CongerResources.com)

    For the person(s) who mistakingly thinks I might be a device, surgeon, or procedure -- of course I'm not! Information is power for those who don't know about yet another device option and serveral provider options; this is more information.
    Last edited by Marti in Benicia; 09-02-2010 at 03:15 PM.

  2. #2
    Senior Member Metalneck07's Avatar
    Join Date
    May 2010
    Location
    Dahlonega ,Georgia
    Posts
    185

    Default Re: M6-L (lumbar) ADR available in Europe

    Marti in Benicia--- You mentioned that M6-L will not be available in the US. Do you mean because presently the FDA has not approved it or do you mean it will never be offered in the US ?? Thanks for the information on this subject.
    Caitlin aka Metalneck07
    Back troubles Teenager-no specific accident ,DDD Lumbar Cervical-Arthritic Facets,etc.
    Cervical Issues- alternative procedures,meds,PT,Diskogram,myelogram
    '07 ADCF C5-6 Surgeon closed shop left me with screws backing out 2months after surgery
    '09 Revsion Surgery C5-6 3 screws had backed out, scarring connective tissue,fluid build up,NonUnion
    '10 complete fusion and Hardware show no issues
    Lumbar issues - DDD alternative procedures,meds,PT,Diskogram verifies L4-5 and L5-S1 pain generators ,Annular disk tear,herinated disk both levels, Facet Hypertrophy
    September 28,2010 On my 40th Birthday I recieved the gift of a new spine.My Prodisc at L4-5 and ALIF at L-5S1.
    Thank you Dr.Blumenthal and Dr.Lieberman you are the BEST.

  3. #3
    Senior Member rhatzy's Avatar
    Join Date
    May 2009
    Location
    Columbus, Ohio
    Posts
    122

    Default Re: M6-L (lumbar) Artificial Disc Replacement Available in Europe

    The FDA takes forever. By the time they approve it, years, their will already be something better oin the market. The US is woefully behind in this area, but hey, you can get your whole back fused here in the US.
    1996 discectomy L4-5
    2007 discectomy L3-4
    Jan '08 maverick at Stenum L3-4, L4-5
    September'08 back to work as airline captain

  4. #4
    Senior Member Carson's Avatar
    Join Date
    May 2009
    Posts
    200

    Default Re: M6-L (lumbar) Artificial Disc Replacement Available in Europe

    Caitlin,

    I communicated with Jacqueline, manager of HR and Admin Services at Spinal Kinetics in email recently to ask the same and she explained device manufacturers are limited in the amount of information they can provide US patients but said the M6 is still "several years out" from the US market. Thankfully both the M6-C and M6-L are available in Europe as mentioned.
    Spine Noob
    April 2007 - Injured one cervical C6/C7 and one lumber L5/S1 in same accident
    No major treatments so far aside from exercising and core strengthening best I can.
    Never, ever, ever, give up.

  5. #5
    Senior Member Metalneck07's Avatar
    Join Date
    May 2010
    Location
    Dahlonega ,Georgia
    Posts
    185

    Default Re: M6-L (lumbar) Artificial Disc Replacement Available in Europe

    Thanks Carson for the information. Unfortunately for me traveling outside the US is not an option.Without Insurance coverage it would be out of our grasp financially.And unfortunately I'm not a candidate for a trial because I have two levels bad. I was really hoping more devices would be approved soon.But it looks like not until some time next year and those will be all metal devices. I just can't wait that long . My weakness and numbness in my right leg is getting worse.Along with my pain becoming hard to manage in my back plus in my right leg. Thanks again for the information.
    Caitlin aka metalneck07
    Back troubles Teenager-no specific accident ,DDD Lumbar Cervical-Arthritic Facets,etc.
    Cervical Issues- alternative procedures,meds,PT,Diskogram,myelogram
    '07 ADCF C5-6 Surgeon closed shop left me with screws backing out 2months after surgery
    '09 Revsion Surgery C5-6 3 screws had backed out, scarring connective tissue,fluid build up,NonUnion
    '10 complete fusion and Hardware show no issues
    Lumbar issues - DDD alternative procedures,meds,PT,Diskogram verifies L4-5 and L5-S1 pain generators ,Annular disk tear,herinated disk both levels, Facet Hypertrophy
    September 28,2010 On my 40th Birthday I recieved the gift of a new spine.My Prodisc at L4-5 and ALIF at L-5S1.
    Thank you Dr.Blumenthal and Dr.Lieberman you are the BEST.

  6. #6
    Senior Member Jack-of-all-trades's Avatar
    Join Date
    Dec 2009
    Location
    mid-NC
    Posts
    304

    Default Re: M6-L (lumbar) Artificial Disc Replacement Available in Europe

    Quote Originally Posted by rhatzy View Post
    The FDA takes forever. By the time they approve it, years, their will already be something better oin the market. The US is woefully behind in this area, but hey, you can get your whole back fused here in the US.
    Sad but true.
    Low back pain became somewhat dehabilitating in 2005
    Have had 11 steroid injections, IDET, Trial for nerve stimulator, PT, chiropractic trial, practically every med known to mankind. Discogram indicated three diseased levels with L5-S1 being the most likely pain generator. Post minimally invasive PLIF with internal fixation (titanium) on 12-28-09 of L5-S1. Doing better than expected. Last opioid 7/9/10. Five months pain free, then my neck turned against me. MRI on 12/1/10-- disease at C2 to C7. Only surgical alternative is to fuse entire C-spine. Diagnosed now with Aggressive Relapsing-Remitting Multiple Sclerosis with cord & brainstem active lesions

  7. #7
    Founder / Administrator Justin's Avatar
    Join Date
    Apr 2009
    Location
    Philadelphia
    Posts
    4,375

    Default Re: M6-L (lumbar) Artificial Disc Replacement Available in Europe

    Marti, thanks for sharing your experience. It was great to catch up today--you are really making great strides with the FDA.

    Keep up the good work.

    Justin Averna
    Founder & President, Spine Patient Society™
    www.SpinePatientSociety.org
    A 501(c)(3) Tax-Exempt Nonprofit & Charitable Organization

    • 1994: Football Injury, Severe Hyperextension
    • 1997: Snow Skiing Injury
    • 3/7/1997, 17 years old: Laminotomy L4/L5
    • 1999 & 2003: Motor Vehicle Accidents (not at fault both times) --> Grade V Annular Tears L4/L5 & L5/L6
    • 11/15/2003, 23 years old: 2-Level ProDisc® L4/L5 & L5/L6*, *lumbosacral transitional vertebra --> Dr. Rudolf Bertagnoli
    • 4/2008: 4.5 years pain-free before "new" leg pain
    • 5/14/2009, 29 years old: Dynamic Stabilization System L4/L5, Dr. Rudolf Bertagnoli
    I'm here to help.
    Questions? Suggestions? Need help with registering, creating a signature, etc.?
    justin (at) spinepatientsociety.org


    Disclosure: I have no financial relationships with any surgeons, spine clinics, device manufacturers, pharmaceutical companies, hospitals, etc. -- the SPS Board of Directors serve without compensation.

  8. #8
    Founder / Administrator Justin's Avatar
    Join Date
    Apr 2009
    Location
    Philadelphia
    Posts
    4,375

    Default Re: M6-L (lumbar) Artificial Disc Replacement Available in Europe

    Quote Originally Posted by Marti in Benicia View Post
    Hello all. I just learned that Spinal Kinetics lumar version of the famous M6-C disc -- the M6-L -- is now approved and commercially available in Europe. They have over 1,000 in patients with excellent success.

    The very first one was implanted by Dr. Nick Boeree in Eastleigh, Southampton (UK). I have names of 3 other surgeons with M6-L experience, too.

    FYI -- The M6-L will not be available in the US; you have to go out-of-country to get it/them.

    No, I don't work for the manufacturer. I've had so much success with my two M6-C discs that I want others to know about the lumbar version. (Marti@CongerResources.com)

    For the person(s) who mistakingly thinks I might be a device, surgeon, or procedure -- of course I'm not! Information is power for those who don't know about yet another device option and serveral provider options; this is more information.
    Hi Marti,

    I found an article that I posted on the Spine Patient Society in September 2009 about Dr. Ritter-Lang being the first surgeon in Europe to implant the Spinal Kinetics M6 Lumbar Artificial Disc Replacement Device.
    I hope this helps others looking for information on the M6.

    Justin Averna
    Founder & President, Spine Patient Society™
    www.SpinePatientSociety.org
    A 501(c)(3) Tax-Exempt Nonprofit & Charitable Organization

    • 1994: Football Injury, Severe Hyperextension
    • 1997: Snow Skiing Injury
    • 3/7/1997, 17 years old: Laminotomy L4/L5
    • 1999 & 2003: Motor Vehicle Accidents (not at fault both times) --> Grade V Annular Tears L4/L5 & L5/L6
    • 11/15/2003, 23 years old: 2-Level ProDisc® L4/L5 & L5/L6*, *lumbosacral transitional vertebra --> Dr. Rudolf Bertagnoli
    • 4/2008: 4.5 years pain-free before "new" leg pain
    • 5/14/2009, 29 years old: Dynamic Stabilization System L4/L5, Dr. Rudolf Bertagnoli
    I'm here to help.
    Questions? Suggestions? Need help with registering, creating a signature, etc.?
    justin (at) spinepatientsociety.org


    Disclosure: I have no financial relationships with any surgeons, spine clinics, device manufacturers, pharmaceutical companies, hospitals, etc. -- the SPS Board of Directors serve without compensation.

  9. #9
    Guest
    Join Date
    Mar 2011
    Posts
    7

    Default Re: M6-L (lumbar) Artificial Disc Replacement Available in Europe

    I am going to toss out some crazy ideas.

    I have contacted my Governor and ask her to legalize this disk in NC. My Argument is if California can legalize pot then why not the M6.

    I tossed this out to spinal kenetics: Sell the disks to the Indians. Indian land is not subject to US law. The FDA has no power there.

    Spinal Kenetic told me that clinical trials are costly in the US and that they think they would get approval but they simply cannot afford to do it. They Told me that there is a surgeon in Mexico City implanting the disk.

    Perhaps US surgeon (one who care about patients more than money) could go to Indian reservations (They have hospitals) and perform the procedure. Spinal Kenetics was intrigued.

    I am in the early process of contacting tribal leaders to see if this is possible.

    Another dumb idea.

    Do it on hospital ships in international water.

    Spinal Kenetics told me that US military members can get the M6 in Germany if they are stationed there.

    It will be many years before this technology is available in the US. Unless we pressure law makers many of us will deteriorate or die before we can have this life saving, yes life saving for me, technology. We are suffering needlessly.

    Please advocate.

    I Suffer

  10. #10
    Senior Member rhatzy's Avatar
    Join Date
    May 2009
    Location
    Columbus, Ohio
    Posts
    122

    Default Re: M6-L (lumbar) Artificial Disc Replacement Available in Europe

    Stenum is a preferred provider for BCBS for some plans. If I had thrown my back out while in Germany and needed surgery then, BCBS would have paid for it.

    Also I have thought about opening a clinic in Bimini,(Bahamas), and running a shuttle from West Palm bringing inpeople for all kinds of surgery and also using a hospital ship in international waters.

    Mark
    1996 discectomy L4-5
    2007 discectomy L3-4
    Jan '08 maverick at Stenum L3-4, L4-5
    September'08 back to work as airline captain

+ Reply to Thread
Page 1 of 2 1 2 LastLast

Tags for this Thread

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts