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 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.