Dascor Nuclear Implant Not Approved By FDA

[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