Healthcare Business

6 Things to Know About Cervical Artificial Discs

In mid-July, the FDA gave final approval for Medtronic to make the first ever cervical artificial disc commercially available in the U.S.: the Prestige Cervical Disc.

Prestige Artificial Disc

The Prestige Cervical Disc is an artificial disc used to replace a problematic disc in patients with single-level (meaning only one spinal disc is affected) cervical degenerative disc disease. Disc degeneration is a normal part of aging, but painful degeneration is caused by a fall, a twisting injury or repetitive wear-and-tear to the cervical spine. Symptoms of cervical degenerative disc disease include low-grade pain from a stiff or inflexible neck and numbness, tingling, or weakness in the neck, arms, or shoulders as a result of nerves in the cervical area becoming irritated or pinched. Cervical fusion surgery is the current gold standard treatment for cervical degenerative disc disease.

So, what do you need to know? A few things:

  1. In general, surgery for neck pain is much less reliable than surgery to relieve arm pain from cervical degenerative disc disease. Thus, if the only or predominant symptom is neck pain, surgery should be recommended only as a last resort or even avoided altogether.
  2. Not all patients who are candidates for cervical fusion surgery are candidates for cervical artificial disc replacement.
  3. Although the Prestige is already in use in Europe, the U.S. clinical study was conducted on 541 people. As a condition of FDA approval, Medtronic must conduct a seven-year study of the device’s long-term safety and effectiveness. One of the big questions with artificial discs, both lumbar and cervical, is just how long the device will last.
  4. The Prestige Cervical Disc was found by the FDA to be as safe and effective as cervical fusion, not more so. The theoretical advantages of discs over fusion include quicker post-op recovery and more flexibility in the neck, but the FDA panel said the results weren’t strong enough to support a superiority claim.
  5. Cost for artificial disc surgery with the Prestige is expected to be about the same as for a cervical fusion – in the $30,000-$35,000 range. Fusion surgery generally enjoys good insurance coverage, while artificial disc replacement coverage, so far only lumbar, has been inconsistent.
  6. The day after the FDA approved the Prestige, Medtronic’s Bryan cervical disc received a recommendation for approval by the FDA (potentially available Winter ‘07). The Bryan is said to more closely resemble a natural spinal disk than the Prestige and could emerge for use in multiple disk replacements at some point in the future. There are also several other cervical discs being studied which may be approved in the next several years.

Artificial discs are a new and potentially exciting alternative for people with pain and disability from cervical degenerative disc disease. However, patients should proceed with caution, especially this early in the game, and be armed with as much information as possible before making a decision about surgery for arm pain and/or neck pain.

Posted by: Sylvia





recently diagnosed

Sat, 04/26/2008 - 21:05
Nichole (not verified)

Good afternoon,

Right now I guess I am writing (typing)lol simply because I just don't know what else to do. I have had scolosis almost all my life although I was not diagnosed until I was about 20. I am now 35, with a beautiful family of my own (2 boys, and a loving husband). When I was a young girl (and yes,,I am going somewhere with this)I was a gymnist for 8 years, and a dancer for 3 years, and after that have always been the mom that is down on the ground with the little kids, exploring life and anything that goes along with it. I could not tolerate my home life as a child, being beaten by my step-mother to the point of which I later found out she punched me one too many times in the face and cut off most of the the blood supply to my condile. After going through treatment for TMJ that was caused mainly but not totally by my lovely step-mother (I would not let them do surgery after 2 of my family memebers had 2 (each person) unsuccessful surgeries)it took 4 years of painful treatment through a wonderful doctor (Dr. Joseph Kerwin) who is the most intellegent person I have ever been in the presence of, and ALOT of cash. Now, after soooo many years of severe pain, I just had a discography done yesterday and a CT,I had already had a MRI which showed some major disc degeneration, a 37% curve in my spine, 2 herniated discs and a bulging disc all above the area they did the discography. Yesterday was one of the most painful days of my entire life, the discography was so painful I was hyperventalating (I am a terrible speller, sorry), and they gave me the maximum amount of sedation allowed, and it didn't feel like they gave me anything at all. I could hear my heart rate racing so fast, I truely think I scared the doctor to death. He just kept saying give her more sedation, over and over,,,til they couldn't give anymore. As the test is going on he is trying to comfort me,,,since now he can see what I am dealing with on his little tv screen. The dye quickly leaked out of the L5-S1 disc space, and the other questionable one L4-L5 had a slower leak and almost no disc left. And that was only the Lumbar part that they checked out, there are alot more problems in the Cervical and Thorasic areas.

I am so scared right now,,I guess its more like terrified! I know what will follow,,,,I have already been told that if they can do surgery (with the 37% curve in my spine)I am very high risk, that I will not be a candidate for the "new" replacement discs, they will not place them in a person with anymore than a 10% curve. I guess I will be receiving one that is better, but I am only 35, and love to be active! My mother has the same problem, and she is now in a wheelchair, so sometimes I wonder,,,do I just live in complete pain,,,very irritable,,,or take the chance that there might be something out there to make me better,,and get me off ALL these pain meds..

I was hoping there is someone out there who might be in a similar boat,,,it is so embarrassing to be walking with a cane at my age, its amazing to have men staring and whistling through the car window, then you step out and can barely walk,,,well its just humiliating! Not that it really matters, as women we just need confirmation that we are still beautiful on the outside too.

My husband,bless his heart (can you tell he has my heart, even after sharing 17 yrs.,lol)now expects me to quit my job, I am an office manager of a interior design firm for the very wealthy. It is a VERY stressful job, and I report directly to the president and I am sure the majority of you can relate he is of the nature that he could care less what I am going through, just do what he wants (I am expected to read his mind on all of the projects, he never tells me what is going on) apparently I am not worthy of his breathe or time,,I am simply "the help". I really cannot stand this man and would love to quit this job,,but really it just feels like one more failure. I don't want that. I have had to fear for my personal safetly there, and have been literally screamed at 2 ft. from my face, and just (in his eyes)will never be good enough even if I walked on water. This stress makes me sooooo tense that I have started chomping at night (my husband has actually counted)41 times a minute sometimes all night long,,,so needless to say when I told Dr. Kerwin about this, he was very upset, and I am back in a mouth piece because I am on the verge of breaking one of my molars, with all of the chomping during my sleep.

Is there SOMEONE out there who has any ideas as to what can be done to help?

I know I have written a book here, but I haven't even scratched the surface. I just keep believing that there is some reason I am having to endure this, love my family and everyone that I come into contact with (well almost everyone)!

Please respond if you have any thoughts on how to avoid any long term complications, or have been through this yourself.

Thanks for your time,

Nichole

Herniated neck disc

Wed, 03/05/2008 - 20:02
Zeagler (not verified)

I was diagnosed with a herniated neck disc that is affecting my spinal cord. I've gone thru physcial therapy, which was some help. The therapist recommended a type of injection that would put a cushion between the disc. I have an appointment with my doctor to discuss this. Haven't been able to find any information on the Internet about this type injection.

I am waiting for insurance

Tue, 12/04/2007 - 01:23
katie singletary (not verified)
I am waiting for insurance approval for the artificial disc replacement. How long did this take for you? what is your story?

Kirstie, Shoot me an email

Tue, 11/20/2007 - 02:12
Adam Wilson (not verified)
Kirstie, Shoot me an email at adamwilson11@gmail.com. I'll reply to you there.

Adam... What did you do to

Mon, 11/12/2007 - 09:01
Kirstie Petersen (not verified)
Adam... What did you do to convince United to cover the disk replacement procedure? I have Blue Cross Blue Sheild HMO, who has ALREADY covered 1 fusion, and the thinkingis that the replacement is next. Would like to know if there are any studies you used which assisted United in making their decision

I wanted to follow up on my

Mon, 10/15/2007 - 23:56
Adam Wilson (not verified)
I wanted to follow up on my 8/22 comment. I continued with more conservative treatment to no avail, but I just received word that United Healthcare will cover the disc replacement surgery. I did lots of research on the disc replacement b/c I agree with the previous posts. Inform yourself and be persistent with your insurance company. If anyone needs help just post here and I'll share my experience b/c it was a struggle.

getting ADR surgery tomorrow (scared)

Mon, 05/05/2008 - 18:15
anniec (not verified)

I'm 29 and I have a herniated disc at c5- c6 also a buldged disc above and nerve damage below all of this from being a waitress for the last 10 yrs.I'm on comp. and it took them 2yrs to cover the surgery this was only after i tried everything else like physical therapy epidural injections andlots of meds.the pain is everyday down my arms and everymorning both hands are swollen burning and tingling.the pain between my shoulder blades is so irritating!i wonder if an ADR is going to take care of all of this. my NS does not explain much to me at all and i ask all the question.he acts like he doesn't have time for me.so here i am tomorrow at 10am i'm gonna get this surgery and i'm so nervous.i'm worried i won't be able to take care of my 2 yr old son.i also have a 12 and 9 year old.can you or anyone tell me how much recovery time i'll need.

I'm currently a candidate

Thu, 08/23/2007 - 04:00
Adam Wilson (not verified)
I'm currently a candidate for the Prestige cervical disc replacement study according to my neurosurgeon. I'm an active and otherwise healthy 24 year old male with a C6/C7 disc herniation that has not responded to 2 months of conservative treatment. The pain in my neck and arms has completely altered my lifestyle so I'm now hoping to have the disc replacement surgery. I've done a lot of research and I think this will be right for me. The biggest issue right now is getting my health insurance to cover the surgery. Has anyone heard of it getting approved by United Healthcare???

I totally agree with Dr Eben

Wed, 08/08/2007 - 18:36
David Jefferson (not verified)
I totally agree with Dr Eben Davis. However it's always good to have options. I think patients should really inform themselves more about this alternative before proceeding. Thanks for this informative post.

Wow, pretty amazing. I still

Wed, 08/08/2007 - 04:24
Dr Eben Davis (not verified)
Wow, pretty amazing. I still think I would want to try nonsurgical spinal decompression first. Not much you can do if it does not help.

We recently had a patient

Thu, 09/06/2007 - 01:52
Dr AJ Vazquez (not verified)
We recently had a patient pay out of pocket. United Healthcare does not like to pay doctors for evidence- based care. I wish you good luck.

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