MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--SpinalMotion, developer of the investigational Kineflex® lumbar and Kineflex® |C cervical disc implants for treating degenerative disc disease (DDD), today 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. 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.
“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.”
Kineflex|C Cervical Total Disc Replacement
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.
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.
About the Artificial Disc Market
The 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.
About SpinalMotion
SpinalMotion is focused exclusively on spinal disc arthroplasty, developing innovative technology designed to enhance options for patients suffering from degenerative disc disease. SpinalMotion was founded in June 2004. The company is located in Mountain View, California. To learn more, visit our website at www.spinalmotion.com.
Caution: Kineflex|C Cervical Artificial Disc is an Investigational device in the United States and is limited by United States law to investigational use. Any forward-looking statements are subject to risks and uncertainties. Actual results may differ substantially from anticipated results.