Spinal Kinetics, the designer and manufacturer of the M6 artificial disc announced that a jury in the United States District Court, Northern District of California, has found that the M6 does not infringe on Synthes’ US Patent No. 7,429,270. The jury found the Synthes’270 patent invalid.
The M6–C cervical and M6–L lumbar artificial discs help patients suffering from degenerative disc disease of the spine; a common cause of chronic and severe back and neck pain. The M6 technology provides an alternative to spinal fusion and is designed to preserve motion and reduce the chances of subsequent degeneration of adjacent discs. Introduced internationally in 2006, according to a company press release, M6 has quickly become a market leader in Europe and is available in over 17 countries worldwide with over 13,500 implants to date.
“We are very pleased with the jury’s verdict in this case,” said Tom Afzal, Spinal Kinetics’ president and CEO. “The interest in the M6 disc is accelerating around the world, and the positive verdict allows us to focus our resources and efforts on making the M6 available to more patients in more countries, including future clinical trials in the USA.”
According to the company, the M6 is the only artificial disc that replicates the anatomic structure and biomechanics of a natural disc by incorporating both an artificial nucleus and annulus. In the USA, Spinal Kinetics has successfully completed an FDA IDE pilot study of the M6–C in patients with both single and two level disease, and has received approval from the FDA to initiate an IDE pivotal study.