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  #1  
Old 08-30-2013, 01:50 AM
papit papit is offline
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Join Date: Aug 2013
Posts: 7
Arrow New here - Seeking Cervical ADR surgeon

Hello everybody. It's good to be here with so many experienced and spine-repair-knowledgeable people.

My main interest at the moment is to identify a few exceptionally skilled spine surgeons in the US as I have decent medical insurance (copayments req'd). I have been diagnosed with noticeable disc degeneration, foramin and spinal column stenosis, and bone spur issues that span C4 thru C7. I want to avoid fusions and probably need extensive bony debris cleanup and at least one ADR. My current doc would prefer to do two ADR's and a fusion.

Can you folks give me recommendations as to who you personally would go to for surgery or a second opinion if it were you? Plus any others as your second choices. Please include where they are located. I'm retired now and otherwise in excellent health albeit no longer a "spring chicken," as some would say! Please post here or PM me.

Thanks in advance.
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  #2  
Old 08-31-2013, 12:06 AM
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jss jss is offline
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Papit,

Condolences on being here and having to make the decisions you're having to make. There is a lot of experience here and hopefully you'll get a lot of replies.

As you're intent on staying in the US, that means ProDisc or Prestige. It's very unlikely that your insurance will cover the Mobi-C. Were I forced into a fusion or ProDisc, my only decision would be Jack Zigler at Texas Back Institute in Plano, TX. He was on the original team to do the FDA IDE for the ProDisc and for years had close financial ties to that device; meaning that he had a great interest in figuring out how to make that device work. He has turned out a years long steady stream of successful outcomes with that device; rivaled only by Dr Bertagnoli in Germany.

Were I in your shoes with the constraints that you've enumerated, Zigler is where I would start.

Good luck, Jeff
__________________
C4/5 - ACDF in 2000
C5/6 - ACDF in 2002
C3/4 & C6/7 - M6 ADR, Nov 2009, Barcelona
Conceded defeat to a manifestly disingenuous BCBS-TX in my quest for reimbursement, Jan 2011
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  #3  
Old 09-02-2013, 05:12 AM
papit papit is offline
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Join Date: Aug 2013
Posts: 7
Arrow

Thanks, Jeff. (Feel free to reply by PM if your prefer.) Your reply is interesting. In round numbers, I wonder what the total cost might have been had you turned to Zigler in Texas instead of Barcelona, and what the total was (excluding piggy-back vacationing) in Spain.

Also, other than financial, were there other considerations that swayed you to Barcelona?

What was BCBC's problem? Was it because it was not done in the US? Would they have gone along with it in the US with doing one ADR and bony debris cleanup (foramin, vertebrae and spinal channel work) for that and the neighboring vertebrae? Until just a few days ago, nobody's ADR appliance was approved for more than one level. I just heard that one, LDR, just got FDA approval for two levels. See below.

August 28, 2013 09:00 AM Eastern Daylight Time
LDR Receives First FDA Approval for Two-Level Cervical Disc Replacement


Mobi-C® Cervical Disc demonstrated STATISTICAL SUPERIORITY for two-level use as compared to fusion control treatment based on the primary endpoint analysis

AUSTIN, Texas--(BUSINESS WIRE)--LDR, a privately held medical device company offering exclusive spinal implant technologies for both non-fusion and fusion applications, today announced that it has received a letter of approval from the U.S. Food and Drug Administration (FDA) allowing the commercial sale and distribution of the Mobi-C Cervical Disc (Mobi-C) for two-level indications, making it the first and only cervical disc in the United States approved to treat more than one level of the cervical spine. LDR previously received a letter of approval on August 7, 2013 from the FDA allowing the commercial sale and distribution of the Mobi-C for one-level use.
“The study data supporting the FDA Approval for Mobi-C represents Level I evidence—the highest level of data classification achievable in the field of Evidence Based Medicine”
“We are very pleased that the FDA, after an intensive review of our submissions, has determined that Mobi-C is safe and effective for both one and two-level indications in the United States, and superior to fusion for two-level cervical disc replacement, based on the results of our prospective, concurrently controlled and randomized, multi-center clinical trials,” said Christophe Lavigne, president and CEO of LDR. “We are proud that LDR is first to offer an on-label, arthroplasty solution for the significant number of patients suffering from two-level cervical disc disease. It is very gratifying to know that spine surgeons can now offer this new, evidence-based treatment option to their two-level surgical candidates.”
Mobi-C is a cobalt chromium alloy and polyethylene, mobile-bearing prosthesis specifically designed as a bone-sparing, cervical intervertebral disc replacement for both one and two-level indications. In addition to the unique mobile-bearing feature, Mobi-C offers a simplified surgical technique as compared to other, commercially available devices, all of which are approved for one-level use only.
In the two-level arm of the Investigational Device Exemption (IDE) trial, Mobi-C demonstrated superiority in overall trial success compared to anterior cervical discectomy and fusion (ACDF), which is a standard option for treating cervical degenerative disc disease. Specific findings comparing Mobi-C to ACDF in the two-level study at the 24-month endpoint included:
  • Mobi-C implanted at two contiguous levels demonstrated statistical superiority in overall trial success compared to ACDF. The difference between Mobi-C’s overall success rate of 69.7% and ACDF’s rate of 37.4% represented statistical superiority (p< 0.0001).
  • The rate of secondary surgery at the index level for Mobi-C was 3.1% versus 11.4% for ACDF.
  • The percentage of subjects who demonstrated negative radiographic changes from baseline in adjacent segments was:
    • 2.9% of Mobi-C patients compared to 18.1% of ACDF patients at the inferior adjacent level; and
    • 13.1% of Mobi-C patients compared to 33.3% of ACDF patients at the superior adjacent level.
  • Mean return to work time was 45.9 days for Mobi-C compared to 66.8 days for ACDF.
  • Mobi-C showed 78.2% improvement in Neck Disability Index (NDI) based on success criteria versus 61.8% for ACDF.
  • Mobi-C is a safe and effective surgical option at two contiguous levels in the cervical spine from C3-C7 for indicated patients.
“The study data supporting the FDA Approval for Mobi-C represents Level I evidence—the highest level of data classification achievable in the field of Evidence Based Medicine,” said Dr. Reginald Davis, Director of Neurosciences at GMBC in Baltimore, Maryland. “As a spine surgeon I have been following the positive clinical data supporting cervical disc replacement over the last several years including the long term evidence. I believe that the two-level Mobi-C study conclusions represent a landmark event in spine, as for the first time it has been demonstrated that on-label two-level cervical disc replacement with Mobi-C represents a superior treatment to two-level anterior spinal fusion.”
“Mobi-C is unique in that it is now the only cervical disc replacement FDA approved for both one and two-level clinical use,” said Dr. Gregory A. Hoffman, orthopedic surgeon and member of the SpineONE Medical Team at Ortho North East in Fort Wayne, Indiana. “The population of patients suffering from one or two-level cervical disc disease is large, and Mobi-C has the potential to make a significant and positive impact to the treatment of those patients.”
“This has been a long and rewarding process,” continued Lavigne. “I would like to thank and attribute this success to everyone involved in this study, especially the clinicians, study coordinators, the FDA, LDR employees, our partners and suppliers, and most importantly the patients who consented to participate in the first concurrent one and two-level prospective study performed comparing cervical disc replacement to ACDF.”
About LDR
LDR, founded in Troyes, France, and headquartered in Austin, Texas, is a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders. Exclusive LDR technologies are based on the Mobi non-fusion and VerteBRIDGE® fusion platforms which have applications in cervical and lumbar spine. In addition to Austin and Troyes, LDR has regional offices in Germany, Spain, China, Korea and Brazil. More information regarding LDR and the Mobi-C Cervical Disc can be found at www.ldr.com and www.cervicaldisc.com. The Summary of Safety and Effectiveness for P110009 is available at www.fda.gov.
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  #4  
Old 09-02-2013, 06:31 AM
papit papit is offline
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Quote:
Originally Posted by jss View Post
Papit,

Condolences on being here and having to make the decisions you're having to make. There is a lot of experience here and hopefully you'll get a lot of replies.

As you're intent on staying in the US, that means ProDisc or Prestige. It's very unlikely that your insurance will cover the Mobi-C. . . .
Good luck, Jeff
I may yet go overseas even though I have BCBS, or maybe because I have BCBS! We'll see.

I don't know anything about the pros and cons or how to compare various manufacturers' artificial discs. Why do you seem to not have high regard for ProDisc? What do you think about Bryan and surgeon Katzman in Florida?
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