Prodisc and the Fda

[LBP]

...

[David]

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!


Dina

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

David

[Bernie_72]

[/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

David[/QUOTE]

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

[LBP]

Dr Yue's website is at:

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

[David]

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

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

[LBP]

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.

[David]

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

David

[Eddie_G]

Originally posted by David:
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!!!

[Dina]

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???

[David]

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

David