A total of 30 patients, with either single or two level degenerative disc disease, were implanted with the M6-C cervical disc. The study was completed at three participating study centers located in North Carolina and California.
In December 2007 the company received approval from the FDA to initiate a study evaluating the M6-C artificial cervical disc with patients suffering from degenerative disc disease of the cervical spine; a common cause of neck and arm pain. These 30 patients will continue to be followed to assess the preliminary safety and effectiveness of the M6-C cervical disc.
Spinal Kinetics’s M6 artificial disc represents the company’s first motion preservation product to treat degenerative diseases of the spine.
Tom Afzal, president and CEO of Spinal Kinetics, said: “The completion of patient enrollment for our M6-C US feasibility trial is a major milestone for our organization and we look forward to the follow up results of these 30 patients.”