CD Horizon® Agile™ (Medtronic Sofamor Danek, Inc. Memphis, TN) dynamic stabilization device was intended to provide posterior dynamic stabilization through a floating cable design that allows for an axial compressive load while retaining constant stiffness. Agile was first used in late 2006 following FDA clearance for use as an adjunct to fusion. The device consisted of pre-curved, lordotic titanium rods with a titanium cable and PCU bumper.
Originally promoted as offering greater motion than the Dynesys device in combined flexion and extension, the device was later recalled by Medtronic Sofamor Danek, due to implant failures that were occurring in both on-label and off-label use. The implants were noted to break due to shear-related failure of the cable component and were noted as being more likely to occur with advanced instability.Medtronic Sofamor Danek USA Inc. recalled its CD Horizon Spinal System Agile Dynamic Stabilization Device for spinal fixation in December 2007. Medtronic has admitted that its device is prone to failure, shearing and cable breaks, which could result in increased pain in the back and legs and/or require removal and replacement surgery of the stabilization devices.
The CD HORIZON AGILE is no longer available.
About Pedicle Screw/Rod–Based Dynamic Stabilization Devices
Dynamic stabilization is a surgical technique designed to allow for some movement of the spine, while maintaining enough stability to prevent too much movement. Pedicle-based dynamic devices were first designed to stabilize the abnormal segment and to unload degenerated discs and facet joints, while maintaining the same level of normal motion.By unloading the pressure on the degenerated disc and facets, pedicle-based dynamic devices have the potential to reduce pain associated with these anatomical structures. Furthermore, these devices can be used to prevent adjacent-segment disease, either by replacing the whole construct with dynamic rods or by “topping off” the rigid instrumented segment with pedicle-based dynamic devices, avoiding an abrupt change from a rigid construct to the more mobile adjacent segment. It has also been argued that using pedicle-based dynamic devices can promote better fusion because of micromovements across endplates, and can protect from implant failure because of better load sharing through the implant. Finally, these devices can be used to stabilize posterior iatrogenic destabilizing surgery, such as wide laminectomy and facetectomy.
About the Spinal Business at Medtronic
Medtronic’s spinal business, based in Memphis, Tenn., is the global leader in today’s spine market and is committed to advancing the treatment of spinal conditions. Medtronic’s spinal business collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art products and technologies for orthopedic and spinal conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies.