ok heres what i found out.from the guy i know at work whom knows some hot shot in the fda.
prodisc failed mfg code 5 10k inspection for tier1 rated device. will be re inspected in 30 to 90 days
once they pass this inspection,offical approval will come in 2 weeks following.
seems this tier1 rating is a prefered insurance rating i suppose meaning more insurance company will pick up the device as standard.
chuck

Any idea how in the hell they could fail an inspection when so much is on the line! Is this common during the appoval process..was it minor any idea if they could fail on a technicality again and be delayed again???? Why isn't the problem being fixed ASAP with an expedited re-inspection. How completely frustrating! I guess I dont really expect any answers, just venting.

all i know it was a type of mgf standard for this tier 1 rating. called 5 10k mfg.
and remember its not a usa company.
probly diff standards {shrug|
chuck

Lovely. Even more waiting for me.....

(could someone please tell me why I didn't select Germany????)

David

The 510K I believe is something that means Prodisc would pass review because it's a similar implant(to one that is already FDA approved) therefore not need to go thru additional FDA type of whatever.. I've forgotten exactly the wording obviously tho this can be looked up easily enough at the fda website.

What I was told by Dr.Yue's office several days ago is that one level Pro disc was FDA approved back in Jan and that what is going to be approved next is the use of Pro disc for 2 level or multilevel implant.

So conceivably if this were true, if the surgeon I saw most recently is requesting to perform a one level ADR with Prodisc and one level fusion which he is, that could conceivably be approved. But if he is requesting authorization for 2 level ADR with Prodisc, it would be non certified or denied again.

I think just to make sure, I'll visit the fda website to see what is stated there, if anything to date re Prodisc.

I did a quick search on the fda.gov site, did not find anything useful...

Mariaa,

there's some confusion because of the wording. The FDA sent the manufac of ProDisc an "approvable letter" but that doesn't mean it's approved as in ready to use on patients yet. The final approval for use on public at ONE level is still pending some inspections and other stuff. So you cannot have a one level ProDisc yet. That is what we are all whining about....chasswen is saying that his connection said ProDisc has failed some inspection standards which will force us to wait longer than hoped and expected. We are not even talking about the 2 level yet. That is a separate arm of the clinical trials that is supposed to be approved sometime (months) after the one level is finally approved.

FYI: 510K is a reference to a section of the law regulating medical devices.

Speculation

Gossip

Third Party Information

Don�t get your panties all in a wad

Be patient and have faith in the process that is really all you can do.

LBP,
I thought Prodisc hadn't been FDA approved even at one level yet, talking with person in Dr.Yue's office gave me different impression. So back to previous knowledge re Prodisc FDA approval. OK.
Re 510K, I know what it is, have seen it already on the fda website ~ however my apologies for being at a loss for words describing what it is. Should not have even made attempt in previous reply.
No worries Paulette~ no panty wauds going on here ~reading that gave me a good little laugh~Hanging in there so far~

Agreed about the gossip part. Stil....I hate to hear anything negative, even when it is just (potential) speculation.

I have pretty much decided to through this year out the window, since I am figuring the change of me having two level Prodisc surgery this year is pretty slim.

So, any potential delays at this part just make my overall wait longer.

[bascially, I just like to complain and whine... Just ask anyone who works with me http://adrsupport.org/groupee_common.../icon_wink.gif ]

David

Home | Contact | Links Welcome to Orthopaedicspecialist.co.uk

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

Hi All,

Just a little humor for a difficult time..... http://adrsupport.org/groupee_common.../icon_razz.gif

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???

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!

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..

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

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?

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.... http://adrsupport.org/groupee_common...icon_frown.gif

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

Trying being a cervie w/a smile on your kisser!
http://adrsupport.org/groupee_common...icon_smile.gif

i think it maybe with how poorly the charite did with the insurance companys.
chuck

Any news yet on FDA approval on this PRODISC?
What's going on?

Unfortunately, that is the $64,000.00 ( 49,947.21 Euro / 34,233.84 GBP) question that pretty much no one here has an answer to.

It is also the same question that most/many of us are interested in (especially us).

If I knew anything, I would be (I can't even say happy, to be honest), less depressed than I am right now...

David

david
how many levels do you need?
chuck
p/s 49,947.21 Euro is that the price they have given you?

I spoke w/ Dr Delamarter just this AM re: my fall at work, (he called me at home what a great doc! That on another channel), but I did ask him what was up about the FDA approval of the ProDisc and he said they are expecting to hear something from the FDA this week or next and he has patents scheduled in 2 week.

Don’t hold me to his word. But I though I would pass it on. He also said that the FDA is being very careful because they felt like they got burned with the Charite. His words not mine.

Can’t wait to celebrate the big day soon! http://adrsupport.org/groupee_common...on_biggrin.gif

Paulette:

Cross my fingers and hope that any Prodisc news comes out in the next couple of weeks.

Of course, I would prefer to hear 2 level news, but even 1 level is a start!

Chuck,

I need two levels, and I believe that Dr. B. quoted me around 29k Euro. I translate that to be around $38k, after all is said and done. The "$64k question" was a vague quote to an old game show, I think.

David

Thanks.

David

I called June second. I even placed a bet with my bookie. He even gave me 12 to 1 odds! (Or was it that he called me odd)
I called 6/2.
Dont make a liar outta me!
C'mon Prodisc........C'mon Babe!!!!!!!!

Oh...... my bad....I meant JULY 2nd.... yeah JULY 2nd
You all know what I meant.

NOBODY....and I mean NOBODY approves Prodiscs on JUNE 2nd.

JULY 2nd is what I meant of course!

heheheh nice try eddie

Ok everyone, I got a call from my work comp nurse case manager, and he tells me that by the end of this week FDA will have approved the Prodisc.
I want so much to believe it and get excited, but its hard anymore believing anything they say.
We all have been put on hold for so long that what they say anymore we dont believe.
David, I have a friend in Ohio who is waiting for a 2 level. And from what I understand, the approval will be for a 1 or 2 level. Heck, it might even be for as many levels as you want. But for real, I say this because he has spoken to someone at the FDA about it.
Anyway, lets all keep our fingers and toes and whatever else crossed for it to happen. If Delamarter is already scheduling, then I believe that this is it. Yes Finally!

...

That would be some excellent news! I wonder if that might be the reason Dr. Y's webpage has significantly changed since I last visited? (I just happened to visit it yesterday)

I seriously hope it is for two level approval, but my guess would be for one level, with two level coming later http://adrsupport.org/groupee_common...icon_frown.gif

David

[/QUOTE]

That would be some excellent news! I wonder if that might be the reason Dr. Y's webpage has significantly changed since I last visited? (I just happened to visit it yesterday)

I seriously hope it is for two level approval, but my guess would be for one level, with two level coming later http://adrsupport.org/groupee_common...icon_frown.gif

David[/QUOTE]

Can you please give me Dr. Y's homepage address? What happened?

Dr Yue's website is at:

http://info.med.yale.edu/ortho/clinical/yue.html

The structure of the page has changed, and now he has listed a lot more surgical trials that he is participating in, along with potential dates...

From an Activ-L prospective, the start date changes. I believe it has changed from:

--2006
--March 2006
--Late 2006
--Late Summer 2006

David

I know this is an old article but I bolded the part I found interesting...I still don't understand why the FDA hasn't yet approved the single level arm of the study. Could Synthes actually asked them to hold off with final approval , until the 2 level arm was approved as well?

see http://www.orthosupersite.com/defaul...=view&rid=5142

I've cut and pasted it below:

New artificial disc awaiting final FDA approval

Once approved, the ProDisc-L will be available in the United States for treating lumbar spine DDD at a single level from L3-S1.


1st on the web (January 9, 2006)



January 2006

Synthes Inc. has received a letter from the FDA notifying the company that its premarket approval application for the ProDisc-L total disc replacement is approvable pending an inspection of related manufacturing facilities, the company announced.

If approved, this will be only the second artificial disc to receive marketing clearance in the United States as an alternative to fusion for single-level degenerative disc disease (DDD).


The ProDisc-L is awaiting final FDA approval as an alternative treatment for lumbar spine DDD at a single level from L3-S1.

COURTESY: SYNTHES INC.

The FDA based its decision on the results of a clinical trial conducted over four years with 292 patients at 17 sites. The study compared the efficacy of ProDisc-L to circumferential fusion on outcomes such as pain and disability, neurologic status, and maintenance or improvement of flexion-extension/range of motion at the index level. Patients were followed for two years postop, according to a press release.

The FDA will issue its approval order for the company’s PMA after it completes and reviews an inspection of Synthes’ Brandywine, Pa., manufacturing facility. Peter Fehlmann, an official in the investor relations department at Synthes, told Orthopedics Today that the FDA has not yet scheduled an inspection date. “We are waiting for it, and it is basically a date that the FDA will decide upon,” he said.

Despite the “approvable” letter from the FDA, Fehlmann noted that the company cannot release study data until it receives the final approval order.

With final approval the ProDisc-L will be available in the United States as an alternative treatment for lumbar spine DDD at a single level from L3-S1. The company is also considering seeking approval for additional indications.

“We did conduct a second arm to the study, which is for multi-level procedures or two-level procedures. But we will first wait for the approval order for the single-level device and then also take into consideration the overall market environment before we decide on how we want to progress with the PMA for the multi-level procedure,” Fehlmann said.
The ProDisc-L is currently available in most European countries as well as some countries in Asia.

I would pay some good $ to find out what the FDA and Synthes are up to....

David

I bet they're on a big yacht together with some Prodisc cheerleaders talking smack about J&J. Then they'll plan a nice junket to Las Vegas while they're figuring out ways to suppress Activ-L and Maverick studies. Then they'll figure out which government official to bribe or invite to Vegas, which bag-man to pay off ect...

What? You thought these people actually CARED about you? BWWAAHAHAHAHAHAHAHAHA

HEY FDA: JUST APPROVE THE D*MN DISC SO I CAN GET MY LIFE BACK!!! YOU APPROVED BOTOX AND BIG BOOBS! HOW ABOUT A HUNK OF METAL FOR MY BACK!!!
SOMEBODY BRIBE HILLARY CLINTON!!! WHATEVER IT TAKES!!! DO SOMETHING PAUL PROCRASTINATOR!!!

Thursday is over and no phone call from Dr. Kropf's office. Do you think they will call me tomorrow?
I doubt it very much. Are we all pissed off or what? This is such b.s. and you are right Eddie they approve so much stuff that is really not necessary, and us injured people who are in need, are having to put our lives on hold for a decision that cant yet be made. What is the hold up???

Upon the advice of my attorney, I decline to answer that question on the grounds that I will probably curse a lot....

David