Status of ProDisc approval???

[mmglobal]

I just received an email saying asking about ProDisc approval. Apparently, this question was asked 3 weeks ago on another forum... still no answer. I'll have to answer it here. The original question was:

What is taking so long to get the ProDisc thru the FDA? Are they waiting to give the J&J backed Charite' a head start?

The ProDisc study population was completed in May 2003 (per a ProDisc principal investigator, presenting at SAS). So, they must wait until May 2005 until all participants are 2 years post-op. At that time, the data will be packaged and submitted to the FDA.

For some time now, people have been saying, "late summer or fall" or "October". I don't know what crystal ball they are looking at. I will be surpised if approval comes before the end of the year.... they may surpise us. They may also surprise us by not coming through with approval until into 2006. The Charite' study population was complete in December 2002. Approval came 11 months later.

Just as we should ask our surgeons to provide supporting data for their medical opinions; if your surgeon is quoting expected approval times, you might want to ask why he believes it to be true. Is there a good reason, or is it just wishful thinking. Why would he want you to believe that we are on the cusp of approval? Please post the answer here.

Mark

[Ksrowd]

Mark,
I mention that exact question to my surgeon (Zigler) who is one of the lead investigators of the entire study. He said the main problem is that the FDA is moving slowly and canceling meetings. He stated that he expects full approval by the end of this year or at the latest Feb/March of next year. I believe his exact quote was "the FDA is moving slower than we had hoped but it should be approved by late this year or worst case scenario would be early next year. When I have my surgery in early July, I will find out as much as I can for you.
Kevin

[Rein]

Kevin confirms what I've been seeing at the FDA site. You can see for yourself by using this link:

http://www.accessdata.fda.gov/script...ory/search.cfm

Select Orth/Rehab from the pulldown menu and the Past Meetings radio button and the Search. You'll see that they've been cancelling meetings for quite a long time. What I'd really like to know is why they manage to hold successive meetings in a row and then skip many, especially since new devices are coming out all the time. Maybe we need to start addressing our complaints directly to the Panel members?

You can also select Upcoming Meetings and see the next four dates. Also, this is where you can access the minutes of meetings on individual devices you may be interested in.

I have a suspicion that individual surgical groups involved in the testing are basing their speculations on when devices may be approved on the above-listed tentative Panel meeting dates, which as we can see is very unpredictable. I do know that Synthes has reps going to each test site to retrieve the latest reports on a very up-to-date basis, so there is no reason to suspect that Synthes did not submit their full report to the Ortho panel in a timely fashion.

[letteski]

Rein

WOW that�s a lot of cancellations! Any reason why?

When do they post the Meeting Details! Great site I�ll bookmark it!

P


P

[Ksrowd]

Paulette,
The actual agenda for the meetings do not come out until a couple of days before the meeting. You can get them from the same web site as soon as they are posted.
Kevin