i was told today from the guy at work who knows someone in the fda,that prodisc PASSED 510K mfg inspection last week for tier 1 level FDA approval.
should be offical in the next few weeks.
YIPPEEE
chuck

Hopefully that is true, as that is excellent news.

The sooner 1 level Prodisc is approved for U.S. usage, the sooner 2 level Prodisc is approved for U.S. usage (and ultimately, the sooner Dr. Y schedules me for surgery)

David

This is great news! I hope that things move along quickly now lol as quickly as the govt in this darn country can move that is and to us who suffer back pain it will never be quickly enough!
Kim

When I was in Dr. Yue's office last Friday I over heard him say just about the same thing. They were doing a manufacturing inspection this week or next and expected the approval in the next month. Mind you this was hearsay, but I think I heard this correctly.

Here's the "business side" of the story from a Swiss news source. It validates the possibility of approval in the "first half" of 2006.
_____________________________________________

28. March 2006, Swissinfo

Synthes comes of age after severing patent ties

Medical devices firm Synthes is well positioned to pursue its strategy of global expansion after buying its patents from an independent research foundation.

Full Article Here.

i told ya so {grin}
chuck

I feel the need to bump this article, in case anyone has any more recent news/info/gossip on the subject.....

Thanks.

David

me sits tapping his foot saying to himself WT!! is taking these bozo fda from getting prodisc paper work done for final approval.
ack
chuck

you already know I agree. The longer this 1 level approval takes, the more doom and gloom my chances are to get the 2 level approved before my state extended cobra ins runs out! TIME is literally running out for me!

agreed 100%.

As I like to say, the FDA runs at two speeds: slow, and stop http://adrsupport.org/groupee_common...icon_frown.gif

David

and in two modes: 'tight-lipped', and 'mute' ! http://adrsupport.org/groupee_common...s/icon_mad.gif


Trace

*cough*, *cough*. Anyone??? Bueller???? http://adrsupport.org/groupee_common.../icon_wink.gif

[hitting Goggle and the Synthes website reveals nothing, unfortunately http://adrsupport.org/groupee_common...icon_frown.gif ]

David

I was wondering the same thing if there was any news concerning this matter? If anyone hears anything please post it for the rest of us ok?
Thanks

Let make a pool. I say it becomes official on June 2.

My timing seems to be working out pretty good actually. My discogram is May 15 (ouch)and my next appointment with Dr. Goldstein is May 22. He prefers the Prodisc as I do so we both agree to wait. I'm ready and very excited!!!

Hurry up already!!!

Anyway JUNE 2 is my bet! Anyone else care to play?

Hmm, if Pro-Disc's approval, I wonder if insurance companies w/be increasingly prone to covering ADR surgery.

My primary concern (naturally) is exactly what is the FDA going to approve?

Is the FDA going to approve single level Prodisc use (and thus screw my life over a bit longer before approving multi-level Prodisc) or is the FDA going to approve multi-level Prodisc usage?

David

David,
I wonder the exact same thing. I have seen Dr.Bae at The Spine Center again in Santa Monica and he has recommended a fusion at L5S1 and Prodisc at L4. I asked about doing a discogram to make sure L3 wasn't bad.
He said Ok, but didn't include any mention of this in his report to WC.

WC sent him a letter asserting a "good faith dispute" because he didn't so some things like sign the report, and other things.

He has been kindly asked to link the proposal for this surgery to the original injury and back everything up with evidence based medicine.

My Primary Treating Physician who I've seen over the last 9 years wants to use Charite at L4 and do a fusion at L5S1 pending discogram which WC denied to decide if L3 was problematic or not...

I held out for going with The Spine Center because of use of Prodisc and possible 2 levels if needed as I thought that was what was going to be FDA approved since it was a 2 level study.

It seems I've made a mess of things now since WC is trying to settle me out, but first to prove there is no relationship between the injury I originally sustained, and surgery being proposed.

See you in Germany?

Those are the questions I keep asking myself:

a. Why didn't I chose Germany?
b. Why do I continue to not chose Germany and play the waiting game?

I really would like to wait for the Activ-L study, but I (obviously) wonder if multi-level Prodisc will be approved within the next couple of months, or if the FDA will hold off on multi-level until possibly sometime next year? And of course, not knowing and waiting is much worse for my morale and borderline depression....

David

i asked the guy at work to ask his friend whats the holdup and his friend said he would look into it.
still waiting soon as i hear something ill talk http://adrsupport.org/groupee_common...icon_smile.gif
chuck

David,
Currently, WC is trying to nail me and probably get something going for a settlement that doesn't offer surgery (so less $)...

I'm trying to get my old attorney's advice (WC)/retain him again ~ if needed, or at least have a consultation.

Re depression.. yesterday was "A day without immigrants" and I live in a very ethnic/latin/other neighborhood so something was up with me and I decided to do some clearing out of "stuff" (made a far bigger mess) and was dancing like back in my 20's/30's to stuff like Iron Butterfly, Tom Petty, The Cars, U2, whatever.. I was so incredibly energized tho boy, did my back hurt later!

Then today, all cranky while home dealing with reality, writing files in reply to my WC stuff, but that got so depressing I changed my env., went out with the dog to visit the dog's best friend and master in downtown and we went up to the 11th floor Solarium and the view of the beach/ocean was so incredible I forgot all about everything that bothered me.

After this we walked around getting something to eat and I just thought "this is it"~ life is beautiful..

More more more of this ~ wherever I land to have surgery~

I've got to call The Spine Center and try to talk to the surgeon proposing the fusion/ADR/Prodisc for me and see what news he has if I can get thru to him.

He was just sent a letter from my WC carrier stating they were holding him in a "good faith dispute" over his report he sent in re surgery proposed. The letter goes on to state what is needed to move forward however, I can see where a technical mistake will get the proposal booted straight back to square 0~ hope someone in that office is familiar with all the new WC requirements~ I don't think he is ...

Let's see a pool .. hmmmm, I like June 2 also and if not by June 2, I say July 4th.. Independence Day! Tho truly hope it's sooner~

well im giving the fda another month for prodisc approval if they are still done nothing i must say its time to contact pro-spine and dr b
i dont think i can wait much longer then that.yesterday i when to bed at 4pm and didnt get out of bed untill 6 am this morning it now feels like bone to bone rubbing. its 3 yrs looking for some resolve 4 or5 surgeons later and nothing ive lost all faith in the american heatlh care and the people whom have the last say aka the insurance companys.
chuck

Chuck,
I called the surgeon's office asking to leave a message to speak w/him re some questions and was told his PA would call me back. She did and she didn't know the answer to any of the questions I asked so she said I could leave a message with the Research Dept and someone would get back with me. That was Wednesday afternoon.

I was just reading the 2nd non cerification I got from UR/WC and am seeing that I probably won't get anywhere with an appeal even unless Prodisc is FDA approved at the very minimum.
Wonder now whether Charite disc replacement at one level would work just as well (fusion at L5S1).. however, even tho FDA approved, am thinking this request for authorization would be shot down as well..

I've already had 2 non certifications for 2 level ADR (one with the trial and Prodisc back in '04 and one recently that wasn't even asking for authorization for surgery but rather giving an opinion and making a referral for someone that could do a 2 level ADR).

The 2nd non cert even goes on to say that fusions (other option for me)yield poor results but have been around for a much longer time (in so many words)..

For me, I believe WC is looking to settle and settle low~ getting out of authorizing surgery altogether no matter how many surgeons proposed it to date...

Ultimately, I am thinking along the very same lines as you~

Hi chasswen,
You can always come to the UK and Mr Lam (We call our top Surgeons Mr - -you keep the Dr thing) who is a wizard with Prodisc. I have lost count of the number he has done- - - - we eat proper food here and speak your language -- -well almost -- - lol http://adrsupport.org/groupee_common...icon_smile.gif

Who ever accompanies you could go sight seeing in London whilst you recover for a few days.

Country Cousins you are always welcome here http://adrsupport.org/groupee_common...icon_smile.gif http://adrsupport.org/groupee_common...icon_smile.gif http://adrsupport.org/groupee_common...icon_smile.gif
Best
Alastair http://adrsupport.org/groupee_common...icon_smile.gif

well i was told activ-l suited me better due to the fact its low profile only 8.5 mm in the rear of the device. im very close if not bone to bone at l4- L5
and have stenois but dr yue says im still a candidate for the study because where the end plates will sit r still pretty good. but in the last few days man it feels like they could be rubbing. marria ill meet in the bogen along with my wife http://adrsupport.org/groupee_common...icon_smile.gif
i dont think i can wait on the fda.
also my wife and i would like to relocate but now the back interfears with that also.
chuck

Chuck
Just read your posts and can empathize big time here I have had a nasty last month increase in pain and been in bed for days straight! This waiting and not knowing anything is for the birds!
Every time I get a new opinion it seems that I am more confused than I was to begin with. What started out here as a sort of moderately difficult decision has come to a much more so one. My last MRI showed more deterioration and damage and more facet involvement so now the question for me is do I go ahead and do the combo fusion/adr that the ins would pay partially for? My OSS is concerned about me havin the Charite now, I am consulting with some docs on this to see what I should do. This is very frustrating and I am about ready to throw in the towel and either look at London or Dr B.
Wish the money was just lying around to do so would have been there already WHEW!
Hope that you feel better soon!
Kim

thanks kim
i wish i had the money kicking arround myseft but i'll have to borrow against the house.but then again it's not much more then my last car so if im ok afterwards all will be ok http://adrsupport.org/groupee_common...icon_smile.gif http://adrsupport.org/groupee_common...icon_smile.gif
enough is enough though
maybe we could all have a party at trace's house http://adrsupport.org/groupee_common...icon_smile.gif
afterwards of course
chuck

Chuck we are in the same boat will have to borrow etc out the wazoo to get the funds to pay for it if I go to Europe. It just galls me to think that in order to have my health I have to be indebted tfor 10 years when it should be a covered expense. I know I am preaching to the choir here and it does get to a point like we are at that its sink or swim.
I mentioned this somewhere jokingly but thought I would throw it in! If all of us who are waiting go at the same time to LOndon or ProSpine maybe we could get a group discount and have a party afterwards? lol
Better to laugh than to cry and my tears are all dried up today

you are 100% correct in it should be a covered expence.but it seems even with the outragous permuims we pay to the insurance company.they have the last say and even after battling BLUE CRAP over adr and being denied all 3 appeals with professions doing the letters. what really gets me is i get caring letters from blue crap acting like they care it just totally blows my mind. but now at this point im begining to feel ill end up less gray hair if i deal with it on my own. sad but true.
chuck

Hey Chuck I totally agree with you and dont want to start a rant here but I think the most infuriating thing is we do pay outrageous premiums to have health care and then we are told that some beaurocrat who cares nothing for us or has any medical knowledge or anything has the right to determine our fate in this! The bottom line for them as we all know is how much money they can hang on to at least one more day to acrrue interest.
I honestly dont know what the answer to our healthcare dilemna is here in the US but I do know our plight is a just a ripple at the surface of a much bigger problem.
U are right in another thing, I can see where by taking control of the situation it would make you feel much better about what u are doing.
I know for me one of the worst parts of this has been the feeling of being out of control and having to cow tow to someone elses thoughts as far as if I deserve treatment for my problems or not.
Good luck and let me know what you decide to do!
I hope and pray that we hear something on Prodisc very very soon!
Kim

...also preaching to the "choir" as well http://adrsupport.org/groupee_common.../icon_wink.gif, but I agree 100% with the both of you as well....

David

Chuck and Kim,
In my case, looks like WC is going to keep me dangling till I settle.. and it could pay for the surgery easily enough, allow me to try to go back on with my life and work again but that is not what is going to happen...

So I'm in the same boat, borrow thousands of dollars and hope I can get back to work to pay it off..

I wish the FDA would get on with the approval of Prodisc.. seems ridiculous to hold this process up, esp. since surgeons are using off label use/practice and doing multiple level Charite replacements (just FDA approved for one level)...

If you two end up in Europe and myself as well, let's party!

Really tempting offer! http://adrsupport.org/groupee_common.../icon_wink.gif

David

im with you guys. im going to try to give the fda a month to get there s!!it together.then i am going to start contact process with pro-spine.
and yes im up for the party maybe we could all rent a vacition house mad party. LOL http://adrsupport.org/groupee_common...icon_smile.gif
chuck

Vamanos Amigos~ http://adrsupport.org/groupee_common.../icon_cool.gif

dann sollen wir gehen? http://adrsupport.org/groupee_common.../icon_wink.gif

David

I couldn't wait for the FDA so I am booked with Dr. Bertagnoli for 6-6-06. Good thing I'm not superstitious. Dr. Yue thinks I should go now before DDD does anymore damage from waiting. Had to take a loan, what a hit even at Germany prices. Any chance any other party animals are on schedule with Dr. B for 6-6-06? Good luck and future good health to all.

Ken - Massachusetts
DDD
Fused L4/5
Herniated L3/4
Bulging L5/S1
Tears in L1/2 L2/3

As the days wear on, I'm very tempted just to take out a loan, and get myself scheduled there as well. June is probably a lovely month in Germany.. (have only been there in the winter)and a good time to go to a Haufbrau house and down a few huge cool ones before going under the knife ( I have to laugh that I would drown in that much beer, and pee my pants all the way back to wherever I'm staying)... but the ambience was great fun tho I was younger and quite well at the time!

Congrats on your booking.. how long did it take you get the date set from point of contact with Dr.B's office?

Mariaa, it was late April when I finally made my decision and contacted Dr. B's office.

Ken

Mariaa, sorry had to cut that message short. The other part is that when I made my decision and asked Dr. B's office to schedule my surgery they had already looked at and examined my MRI, Discography, Xrays and CT scan and associated doctor's reports.
Ken