FDA Approves Paradigm Spine, LLC's Cost-Saving Coflex Spinal Stenosis Treatment
10/18/2012 8:44:52 AM
Paradigm Spine wins FDA approval for the 1st device that treats moderate to severe spinal stenosis with or without back pain, with study results finding that the device preserves motion and saves costs compared with traditional pedicle screw fusion. Paradigm Spine won FDA approval for its Coflex spinal stenosis treatment system, the 1st such device to treat moderate to severe cases of spinal stenosis that may present with or without back pain. Paradigm calls the Coflex device the "the 1st and only motion-preserving alternative to fusion for the treatment of moderate to severe spinal stenosis." The approval was based on clinical results from the company's investigational device exemption study that compared the Coflex device to pedicle screw fusion, the current standard of care. The results showed that Coflex met or beat fusion in all major primary and secondary endpoints, Paradigm reported. Coflex patients spent 40% less time in the hospital and surgeries were performed 36% faster, according to the study. In addition, 85.5% of Coflex patients reported improvements in pain and function after 2 years, compared with 76.7% of patients who received the current standard of care.