[DASCOR] FDA Trial not approved

[Rev. Zen]

I thought I would put the word out for anyone that was interested in the DASCOR IDE trial that was scheduled for this year. I had been eagerly awaiting the trial as I was hoping to get this procedure done on my L5-S1. I had been keeping in regular contact with Carol Dorn at Disc Dynamics. I had last heard from her back in November of 2009 and it sounded like everything was moving forward with the IDE study for 2010.

I waited until after the holidays to try and touch base with her again. WHen I sent her my next email (earlier this month) the email got bounced back. So, naturally I went to the website to see if anything had been posted. Their website had been taken down.

After a little bit of searching with google maps, I found a phone number and contacted Disc Dynamics. I got through to an operator who then informed me that Carol was not with the company any longer and she also informed me that the IDE tiral did not get approval.

I really had my heart set on the nucleus replacement procedure versus the traditional ADR devices (ProDisc and Charite). I guess I will start back at square one to see if any of the other nucleus replacement options have faired any better.

If anyone has anything promising to offer, I could really use some good news. I had pretty much put all of my eggs (and hopes) into the DASCOR basket...

[nurse4kids1979]

HI,
I am a Dascor patient, and was just notified a few weeks ago, about the trial not getting approved. However, NO ONE knows why. They just claim that they couldn't give the FDA the information that they needed.

I personally, have had great success and I know about 10 others that have as well, and probably lots more... keep searching. I do know of quite a few who have gone to Germany to have the same proceedure... might check out that option as well.

Good luck!!

[Johnny Vegas]

I am about a year and a half post op from Dascor. I am about %80 pain free. I plan to find out as much as I can about the proceedure and the old company. Good luck in your search. I will let you know if I can find anything out.

[Johnny Vegas]

I have spoke with my old Dascor rep and she has assured me that there is nothing wrong with the device itself. The company could no longer bear the weight of the debt for approval to get the device on the market. She expects to hear that the company's technology will be bought and the device to eventually be on the market.

[Rev. Zen]

That is very promising news. Thank you for the update, JV.

I just hope that this happens very soon. I do not want to wait too long and end not being elligible for it. My initial concern in this regarsd, is that my disc height could be getting smaller by the year/month/day. Once it gets down too far, then they may not have any alternative but fusion. At least , that is my understanding of it.

If DASCOR pops up on my radar soon, I will jump at it!!

[hayzer912]

Sorry to hear about Dascor. Have you heard of the Nubac Trial? Thats a nucleus replacement implant that I researched and was disqualified for recently because I have multiple levels of DDD. If you have only one you may qualify for this device. Just a thought.

Kelly

[Rev. Zen]

Originally Posted by hayzer912

Sorry to hear about Dascor. Have you heard of the Nubac Trial? Thats a nucleus replacement implant that I researched and was disqualified for recently because I have multiple levels of DDD. If you have only one you may qualify for this device. Just a thought.

Kelly

Yeah, I researched the Nubac trial as well. I am excluded due to the fact that they will not work on anything below the L5 vertebrae (my DDD is in my L5/S1).