Other Product Data

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 Rationale

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 Testing

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.

 

Clinical Validation

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.