Disc Replacement Device for Spinal Applications Approved
The ProDisc-C Total Disc Replacement, designed and manufactured by Synthes, Incorporated has received approval from the FDA. The company issued a press release detailing the news of the approval for marketing and distribution in the United States.
The product is for patients with disease of the cervical spine. The Pro-Disc is implanted after removal of the damaged disc. It both provides for normal motion at the affected level of the spine in addition to restoring the disc height. The ProDisc-C is intended to reduce the pain patients experience secondary to degeneration of discs in the cervical spine.
Clinical review of the device was completed at the end of October. The remaining components of the review, which required assessment of the device manufacturing, were completed. The device already received the CE mark and is being used in Europe.
Training for surgeons who plan to use the ProDisc-C is expected to start early next year followed by a phased role out of the device.
With this approval, Synthes now has products available to treat patients with disease of either the lumbar or cervical spine. The organization specializes in device development for soft tissues and the skeleton.
December 26, 2007 Related topics: Surgery, Orthopedic