A Medical Device Daily
Spinal Kinetics (Sunnyvale, California), a maker of artificial disc technology, said that it has successfully completed patient enrollment in its M6-C artificial cervical disc U.S. feasibility study.
A total of 30 patients, with either single- or two-level degenerative disc disease, were implanted with the M6-C cervical disc.
The M6-C is the company's first motion preservation product to treat degenerative diseases of the spine. The M6-C is an artificial disc designed to replace an intervertebral disc damaged by cervical disc degeneration.
The disc's compressible polymer nucleus is designed to simulate the function of the native nucleus, while the surrounding multi-layer, high-tensile-strength fiber annulus is intended to facilitate a controlled range of motion in multiple directions.
The M6-C is implanted with surgical instrumentation that was designed with surgeon feedback.
"Overall, we were extremely pleased with the intra-operative performance of the M6-C cervical disc, as well as the simplicity and ease of implanting the device during the study," said Thomas Dimmig, MD, principal study investigator from Triangle Orthopedic Associates (Durham, North Carolina).