StabiliT Vertebral Augmentation System
The StabiliT™ Vertebral Augmentation System for treating vertebral compression fractures is comprised of proprietary StabiliT ER Bone Cement and delivery system. This offers the physician on-demand control of the viscosity of the bone cement as it is injected into fractured bone. Providing ultra-high viscosity bone cement may minimize the potential for extravasation. The StabiliT Vertebral Augmentation System enables the cement viscosity to be controlled by warming it with the application of energy in the delivery system, thereby accelerating the polymerization process.
DFine’s innovative system allows the physician to perform a streamlined minimally invasive procedure which can make a single percutaneous injection site possible. The injection of ultra-high viscosity bone cement forms an internal cast for stabilizing the fracture. The stabilization of the fracture reduces micro-motion, which in turn may help eliminate pain. StabiliT Vertebral Augmentation System’s streamlined injection of ultra-high viscosity bone cement also may be used to apply mechanical forces in vertebral augmentation in an effort to maintain and restore spinal function, and to address fractures with greater specificity by localizing cement deposition in a vertebra.
StabiliT ER Bone Cement
The StabiliT ER Bone Cement is a proprietary energy responsive PMMA-based cement that can increase viscosity on-demand by applying energy. The material is specially formulated for its energy sensitive attributes — to provide an optimal ultra-high viscosity cement which can be delivered over an extended period of time.
Energy applied to the cement results in the delivery of a cohesive ultra high viscosity, yet flowable, cement delivered into the vertebral body minimizing its tendency to extravasate.
Vertebroplasty: Low viscosity bone cement injection
Cross section of human cadaveric vertebra with low viscosity bone cement |
StabiliT Vertebral Augmentation: On-demand ultra high viscosity cement injection
Cross section of human cadaveric vertebra with StabiliT ER Bone Cement |
The StabiliT Vertebral Augmentation System is available exclusively for Clinical Investigation in the European Union.
The StabiliT Vertebral Augmentation Systems is commercially available in the United States. Federal (USA) law restricts the device described in this website to sale and use by or on the order of a physician.
U.S. and foreign patents pending.
|
