StabiliT Vertebral Augmentation System - Radiofrequency Kyphoplasty by DFine Inc
The StabiliT Vertebral Augmentation System and the VertecoR Osteotomes shown here, offer a unique evolution in the treatment of vertebral compression fractures. Together these products represent the procedure termed RF Kyphoplasty. RF Kyphoplasty is the next generation in kyphoplasty combining the benefit of ultra high viscosity bone cement with cavity creation, potential height restoration and the potential for reduced operator radiation exposure.
The StabiliT Vertebral Augmentation System contains StabiliT ER2 Bone Cement and ER2 Saturate Mixing System, Multiplex Controller, Hydraulic Assembly, Activation Element and AE Cable, 2 StabiliT Introducers with one diamond and one bevel tip, VertecoR StraightLine Cement Staging Osteotome, VertecoR MidLine Cement Staging Osteotome, Locking Delivery Cannula, and the Hand Switch Cable.
The Multiplex Controller regulates the application of radio frequency energy and controls the automated hydraulic delivery of bone cement. It also displays user-friendly instructions to the physician and staff.
The system allows the user to deliver energy to the StabiliT ER2 Bone Cement, significantly increasing its viscosity as it passes out of the delivery system. This enables delivery of ultra-high viscosity cement 4-10 times greater than other bone cements on the market.
This side by side comparison demonstrates the change in viscosity of the energy responsive bone cement when radio frequency energy is applied. Here, you can see cement with and without energy. Both cements were mixed at the same time and temperature. The cement that has passed through the activation element is an ultra-high viscosity forming a bolus at the end of the cannula. The cement on the right, without energy, remains runny and continues to drip.
To perform RF Kyphoplasty, the StabiliT Introducer is used to gain access to the vertebral body. VertecoR StraightLine Cement Staging Osteotome is then utilized to create a cavity. The VertecoR MidLine Cement Staging Osteotome is then utilized to create a cavity within the center of the vertebral body. Next, the locking delivery cannula attached to the Activation Element is placed through the working cannula into the vertebral body and ultra high viscosity bone cement is delivered into the Osteotome created cavity. As the StabiliT ER2 bone cement fills the cavity, it expands on top of itself, applying a load across the surface area of the cavity driving potential height restoration of the fracture. It is the cement viscosity that drives the potential for height restoration.
The Hand Switch Cable which starts and stops the flow of ultra high viscosity cement allows the operator to remain up to 10 feet from the patient's side during cement delivery providing controlled cement delivery with the added advantage of potentially reducing radiation exposure.
The StabiliT Vertebral Augmentation System: Redefining the treatment of vertebral compression fractures.
The information provided is not a substitute for professional advice and should not be relied upon in the absence of such professional advice specific to whatever facts and circumstances are presented in any given situation.