CE Mark for Spinal Motion’s Sub-5mm Kineflex®|C Cervical Total Disc Replacements

“…we believe we now have the widest range of cervical disc heights to most effectively match patients anatomy with a goal of optimizing motion and long term stability”

In short

Californian artifical spinal disc company SpinalMotion has announced that it has received CE Mark for two sub-5mm Kineflex|C cervical total disc replacements to address the widest range of patients by best matching disc height to the existing anatomy.

Background

According to Spinal Motion’s press release, the (US) National Center for Health Statistics reports that 14% of new patient visits to physician offices (approximately 13 million annually) are for complaints of lower-back and neck pain. In fact, an estimated 18% of the population has debilitating back pain at any given time.

Founded in 2004, SpinalMotion is focused exclusively on spinal disc arthroplasty, developing innovative technology designed to enhance options for patients suffering from degenerative disc disease.

The Kineflex|C Cervical Total Disc Replacement is a semi-constrained, mobile bearing disc made of Cobalt Chrome alloy chosen for its strength, wear characteristics, and durability. The Kineflex|C 4LH disc height of 4mm, and the Kineflex|C 5LH disc height of 4.8mm, enable surgeons to treat patients with smaller disc heights without overstretching the adjacent ligaments, which could limit motion.

Company comments

“We look forward to adding our lower height Kineflex|C discs to our product line internationally, and we believe we now have the widest range of cervical disc heights to most effectively match patients anatomy with a goal of optimizing motion and long term stability”, said David Hovda, SpinalMotion’s President and CEO. “The kinematics of our new discs are identical to our existing Kineflex|C discs, and the implant technique and instrumentation are very similar to the discs we have used commercially and in our IDE clinical study.”

Note: SpinalMotion has conducted an IDE clinical study of the Kineflex|C disc compared to anterior cervical discectomy and fusion in the United States, and submitted its PMA in 2010. The PMA is currently under FDA review, and the product is not available for sale in the United States, as it is currently cleared for investigational use only.

Source: Spinal Motion Inc