DASCOR® Disc Arthroplasty System -- Disc Dynamics Folds, Unable to Secure FDA Clinical Trial Approval

[Justin]

I received the information below from a Spine Patient regarding the DASCOR® Disc Arthroplasty System.

Dear XXXXX,

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.

[Keano16]

Patients who had this implanted will definitely have problems.

[sportsnut3007]

Keano why do you say those who had this implanted would have problems? The device itself or the fact they are no longer a company and they people will have to find someone to take it out if it breaks out?

[Keano16]

Disc Dynamics R.I.P. -- The Spine Blogger __

[Rev. Zen]

This was a real heartbreaker for me. I had hoped to get into the IDE trial this year. I been in frequent contact with Carol Dorn of Disc Dynamics. Then when the first of the year rolled around, their website went down, the emails got bounced back to me and the phone number went straight to voicemail.

Are there any clinical trials coming out soon that would be similar to DASCOR (nucleus replacement versus full disc replacement) for an L5-S1 disc?

Help!

[Keano16]

There will not be anything similar soon. I've recently listened long video web cast on this, and one doctor told this.