Dascor Nuclear Implant Not Approved By FDA

[nurse4kids02]

Well i had the dascor implant back in feb 2007, and yesterday was notified it was NOT approved by the FDA. The company shut down, fired all employees, and is no longer in existence. They also stopped paying all bills. I have not been able to find anything online regarding it. Anyone have any information?

[mmglobal]

nurse, what are you hearing from your doctor?

Who has responsibility for long-term issues. Presumably, very dangerous materials and procedures would not make it into clinical trial. (famous last words?)

Thanks for keeping us posted about the company. What is happening with you and other patients you know?

All the best,

Mark

[nurse4kids02]

Ya i asked Dr. Regan what will happen now. I can't go to his office anymore, cuz insurance won't pay for it. They are still trying to get in contact with someone from that company (well since they don't exist anymore), but not thinking they are having luck.
I wrote to the ombudsman for the FDA, but have not heard back. Can't find anything on the internet about it. Pretty much like it all disappeared. From what I gather, it only made it to 140 people... so, not very many.
So not sure what will happen, but if something is going wrong... I would like to know, and get this thing out.
However, I am comforted by the fact that Germany has been using it for many years, but, not sure if our implants are made out of the same material they are using...
So seems like everything is just up in the air...

[New-disc]

Please keep us posted...

[nurse4kids02]

This is the letter i got from Dr Regan:
RE: DASCOR® Study Closeout; IDE G030125

Dear Melissa:

Thank you for your participation and valuable contribution in the Study of the Disc Dynamics DASCOR® Disc Arthroplasty System in the Treatment of Degenerative Disc Disease.

Disc Dynamics, Inc., Sponsor of the DASCOR® Study, had informed us that since the start of operations in May of 2000, the company secured in excess of $65 million to fund the development of the DASCOR® Disc Arthroplasty System. The Company completed numerous bench and animal studies assessing the safety of the Device and System. Clinical studies on 125 patients have been underway in assessing the effectiveness of the Device in helping resolve pain for back pain patients with degenerative disc disease. The DASCOR® System received CE Mark approval in Europe and was sold on a limited basis over the past three years. Unfortunately, Disc Dynamics, Inc. was unable to obtain United States Food and Drug Administration (FDA) approval to start a Pivotal clinical trial in the United States. In response to their most recent submission to the FDA requesting permission to begin a US Pivotal clinical trial, the FDA once again requested additional data. Unfortunately, the difficult financial market conditions, as well as the FDA’s decisions, prohibited Disc Dynamics, Inc. from securing additional financing.

Having exhausted all possible opportunities for funding and with its operating funds almost depleted, Disc Dynamics, Inc. commenced a wind down of its business and, effective December 31, 2009, has terminated all of its employees and discontinued all financial support of clinical studies.
The Food and Drug Administration and Disc Dynamics, Inc. suggest you continue to follow up with your implanting surgeon or a physician of your choice. Please continue to report any health concerns to your implanting surgeon.
If you have any questions please contact your implanting surgeon and/or a Study Coordinator. Once again, thank you for your participation in the DASCOR® Study.
Sincerely,
John J. Regan, MD