Prodisc and the Fda

[Alastair]

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Upper Limb Disorders
Lumbar Disc



What does the FDA and NICE say?

Artificial disc use is currently in different phases of development and clinical trials in the United States under strict FDA (Food and Drug Administration) guidelines3,7,9,10, but has been used in a number of European countries for over 10 years4,8. There has been nearly 20 years experience in the use of the Charit� III (unconstrained) and ProDisc II (semi-constrained), both of which have completed their randomized enrolments, and are currently in Continued Access non-randomized modes. The Maverick (metal on metal articulation) and FlexiCore lumbar discs are actively enrolling patients with single-level disease.
There are a wide selection of new products, procedures and techniques currently in development to enhance spine surgery with artificial discs, and many spine surgeons believe that artificial disc technology holds real promise for significantly improving the standard of care for many patients. Provisional comparative data from the larger investigational study centres reveals improved visual pain analogue score (VPAS) and Oswestry low back functional scores in arthroplasty patients, and suggest earlier return to work with restoration of lumbar motion as compared to the control fusion group5,9,10.

Results of the FDA multi-centre randomised study on the Charit� III have been released showing significantly more patients improving following disc replacement than those who had a fusion1. Results of the Prodisc II study are also very encouraging and will be released in late 2005. Based on the Charit� III study, NICE have issued full guidance for lumbar disc replacement.

(Further information about the National Institute for Clinical Excellence (NICE) and the Interventional Procedures Programme can be found on the NICE website (www.nice.org.uk). A copy of the full guidance on prosthetic intervertebral disc replacement is on the NICE website (www.nice.org.uk/IPG100guidance), or you can order a copy from the website or by telephoning the NHS Response Line on 0870 1555 455 and quoting reference number N0749.)








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http://www.orthopaedicspecialist.co....andNICEsay.htm

well prodisc hasnt been approved for the public only a letter of aprovable was sent meaning fda had to do mfg and packaging inspections.
tier 1 device approval
is a prefer insurance thing meaning its the way the company wants this device approved,meaning more insurance companys will pick up the device if its done in this fashion.
was how it was explained me.
510k was what they failed for.
next inspection 30 to 90 days and once they pass that inspection device will get fda public appoval 2 weeks after.
i'm waiting my self and r not trying to pop anyones bubble.
chuck

[letteski]

Hi All,

Just a little humor for a difficult time.....

How about this idea if you have not already you can sign up to receive email news from Synthes. If you look under the news link on the left you can see there was news yesterday that had to do with the FDA but nothing to do with the ProDisc. I would not call this great news for Synthesis but maybe it shows that they share all types of news if there is news to share.

Paulette,

I assume your one liner "Just a little humor for a difficult time....." is in response to my email to you when I expressed my opinon that your other posting was a little insensitive. Why do you have to continue with the one liners?

Was there anything funny about your fight to get your prodisc surgery. There is nothing funny about any delay the rest of us must endure. Have you forgotten how stressed, worried, and frustrated you felt before you got your life back. Please dont be so flip about our continued fight and never ending waiting game.

"Don�t get your panties all in a waud
Be patient and have faith in the process that is really all you can do." Come on...is this something you would have wanted to read from an ADR recipient before you became part of this exclusive club???

[Eddie_G]

I am suffering just as much as anyone on this board and appreciate any humor attempted here. We Spineys have to deal with so much BS and red tape, a little levity is OK with me. Why cry when we can laugh? I could easily do both at this point. I take the jokes with a grain of salt because in between them is GREAT information that I need to get my life back.

Maybe we can get Larry David on here to make us feel better.

Whenever I look at the dark disk on my MRI, I start singing AC/DC's "Back In Black" since my back ....is....well.........black....no?
uh...nevermind.....

I'm no Bob Hope but I still have some!

[Mariaa]

I think Paulette was just interjecting a bit of humor into our posting. I've known Paulette for a while from this forum, she's been really instrumental in getting me to Spiney get- togethers I otherwise wouldn't have gone to, so I know she's a very supportive person personally.

While she was going thru her own personal Spiney struggle she supported So many people on this forum for months. She was an excellent recource person, and always had something noteworthy to say/report, and intelligent questions to bring to the doctors.

She still comes back here to post, even tho her life no longer is one of pain and struggle..

The panties in a wad statement was humor..nothing more..

[Harrison]

LBP,

Paulette�s positive manner is appreciated by many here, if not everyone � as you can see from Eddie and Maria�s post. Frankly, I wish we could clone her and have more Paulette�s providing helpful and supportive posts.

I find your particular post very confrontational, unnerving and perhaps even in conflict with our carefully designed guidelines:

4. Please treat others as you would expect them to treat you. Personal attacks or any type of "flaming" of other community members will not be tolerated. Refrain from personal attacks and abusive language - use constructive criticism (e.g. criticize the logic, ethics, or interpretation), not destructive criticism (e.g. personally attack an individual, their writing style, post member�s private emails without permission, etc.)

Paulette, on a more serious note, you should know that I have received many complaints about your post. There are too many to list here, but here are a few excerpts from certified letters sent to my house just this morning:

��there is no such word as �waud�...�

Madge Orrity, Merriam Webster Online Editor

��we object to the insinuation that panties cause bunching, dermatitis or any other annoying condition. This allegation is baseless. If operators of panties read the instruction manual and follow SOP, they will luxuriate in comfort all day long��

Laura Norder, American Panty Union

[LBP]

Anyone talk to Dr Yue to see if he knows more about the status of FDA's approval of Prodisc? Since the one level received an "approvable letter" back in Jan and now we are almost in June with no final approval to market the damn thing....are they in fact waiting the 6 mos for the 2 level arm of the study to get approval before releasing any of them out to the market? Is this an insurance coverage strategy????

Anyone have a clue about this?

[David]

I have basically the same questions that you do....

I spoke to Dr. Y right after the "approvable letter", and his statement was that the Activ-L study would start with the one level segment, and then proceed to the two level segment at a later (undetermined) date. (I haven't heard anything about waiting to release both the 1 level and the 2 level at the same time..)

But, as you state, it is now nearly June, and we still haven't heard anything from the FDA concerning Prodisc (although Dr. Y did think that something related to Prodisc would be announced during the SAS 6 [which, of course, didn't happen]).

So, here we both wait, wondering when something might happen....

Edit: Ultimately, I wish I had some information. If I had any kind of time-line to look forward to, then I would have a goal of some sort. Since I don't, I am seriously thinking about hopping the big ocean to Germany for surgery....

David

[biffnoble]

Trying being a cervie w/a smile on your kisser!