MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--SpinalMotion, Inc., developer of the investigational Kineflex® lumbar and Kineflex® |C cervical disc implants for treating degenerative disc disease (DDD), today reported that it has started enrolling patients in an international clinical study evaluating the Kineflex|CI cervical artificial disc designed to optimize MRI imaging following disc implantation.
Current cervical disc designs primarily utilize either cobalt chrome or titanium metal endplates that can cause interference with MRI imaging at the level of the disc replacement. Surgeons have indicated a disc replacement that minimizes MRI interference could potentially improve patient follow-up and provide important clinical information as an alternative to CT scan. The Kineflex|CI disc is comprised of a core made of ceramic and endplates made primarily from PEEK, a polymer commonly used as a spacer in spine surgery. These materials do not create interference on MRI and are commonly used with other spine surgery or total joint replacement applications.
“The Kineflex|CI cervical disc prosthesis is an excellent option for treating cervical disc disease because it uses a clinically-proven design with materials that do not interfere with MRI imaging,” said Louis Nel, Jr., M.D., Senior Spine Surgeon at Zuid Afrikaans Hospital in Pretoria, South Africa. “The implantation procedure is identical to the Kineflex|C cervical disc and the instrumentation is the same as well. We continue to evaluate our patients and look forward to reporting long-term results.”
“We are excited to begin clinical investigation of our Kineflex|CI cervical disc and we believe it will add clinical meaningful benefits for surgeons and their patients for treating degenerative disease in the cervical spine,” said David Hovda, SpinalMotion’s President and CEO. “We continue to make progress on our cervical and lumbar PMA submissions, and we look forward to working with the FDA to obtain market approval.”
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, Kineflex|C, and Kineflex|CI Spinal Systems are Investigational devices in the United States and are 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.