SpinalMotion, Inc., developer of the investigational Kineflex® lumbar and Kineflex®|C cervical disc implants for treating patients with degenerative disc disease (DDD), today reported that it has completed enrollment in an international clinical study evaluating the Kineflex lumbar artificial disc inserted via a minimally invasive lateral approach. The data from the study will be used to support regulatory submissions for international commercialization.
“We are pleased with our progress, and look forward to working with the FDA to obtain market approval and support surgeons and patients in treating degenerative disc disease.”
"The Kineflex lateral disc prosthesis is an excellent minimally invasive option for treating lumbar disc disease," said Louis Nel, Jr., M.D., Senior Spine Surgeon at Zuid Afrikaans Hospital in Pretoria, South Africa. "The implantation procedure is straight-forward and my patients have done well clinically with short recovery times. We continue to evaluate our patients and look forward to reporting long-term results."
The company also reported that clinical investigators will present four podium presentations on the Kineflex disc replacement Investigational Device Exemption (IDE) clinical studies during the 25th annual North America Spine Society Meeting (NASS), which started today in Orlando, Florida. Two presentations will cover the Kineflex|C cervical disc; one of which was selected for the Best Papers section. The other two presentations review the Kineflex lumbar disc. All four presentations will cover the respective clinical and radiographic results from the IDE studies.
"We have submitted Pre-Market Approval (PMA) applications to FDA for both the Kineflex|C and Kineflex lumbar discs," said David Hovda, SpinalMotion's President and CEO. "We are pleased with our progress, and look forward to working with the FDA to obtain market approval and support surgeons and patients in treating degenerative disc disease."