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coflex-F® Clinical Data
Paradigm Spine has clinical data available for the coflex-F® Stabilization System. Clinical studies demonstrated that the coflex-F® device can replace a pedicle screw system by demonstrating great pain relief with the benefit of shorter, less invasive surgery.
Biomechanical studies demonstrate that the solid interlaminar anchoring of the coflex-F® implant through rigid fixation to the spinous processes and laminae provides similar posterior stabilization as pedicle screws, thereby increasing the likelihood of successful anterior fusion (Table 1).
Comparative mechanical side-by-side testing using a clinically valid test protocol demonstrates that the coflex-F® design results in a stronger and stiffer environment to stabilize the motion segment compared to other spinous process plates (Table 2).*
*Internal data available at Paradigm Spine. This product is covered under U.S. Patent Nos. 5,645,599 and 7,922,750, as well as other pending patent applications in the U.S. and internationally.
A prospective, non-randomized postmarket surveillance study with six surgeons and 68 patients has shown the following results:
In addition, the fusion rate, using established radiographic criteria, was achieved in 95.2% of the treated patients. The clinical data have validated the biomechanical experience. The coflex-F® device is a safe implant that achieves fusion.