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StabiliT RFK

StabiliT Vertebral Augmentation System – Radiofrequency Kyphoplasty (RFK)

Unique control in the treatment of vertebral compression fractures

The StabiliT Vertebral Augmentation System is a fully integrated state-of-the-art system that represents precision-controlled advances and safety in the treatment of VCFs.

Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). The StabiliT Vertebral Augmentation System is intended for percutaneous delivery of StabiliT ER2 Bone Cement. The StabiliT ER2 Bone Cement is indicated for the treatment of pathological fractures of the vertebra using a vertebroplasty or kyphoplasty procedure.

How does RFK with StabiliT work?

Unipedicular Access

As part of StabiliT, the PowerCURVE Osteotome allows unipedicular access that enables targeted cavity creation across the vertebral midline. This can be achieved by turning a canula with bent tip up to 90 degrees. The cement can be retrogradely distributed across the whole vertebra and the cannula can be removed and reinserted if necessary.

The articulating PowerCURVE Osteotome allows an unipedicular access across the vertebral midline.

PowerCURVE Osteotome

The cannula with navigated tip allows for a three dimensional navigation in the vertebra.

High cement viscosity

The StabiliT Vertebral Augmentation System includes a second important component: The bone cement ER2. Its viscosity can be increased by radiofrequency energy. The user can process this cement in its inactivated state for up to 30 minutes and remote controls the application. The MultiPlex Controller ensures a controlled bone cement delivery rate by a hydraulic assembly to maximize interdigitation and fracture stability.

The activation element activates the cement with radiofrequency energy

High cement interdigitation

Despite its ultra-high viscosity, cement interdigitates extremely well with the trabecular bone. The picture shows the high overlap of cement and vertebra.

Results

Comparison of Clinical and Radiological Data in the Treatment of Patients with Osteoporotic Vertebral Compression Fractures Using Radiofrequency Kyphoplasty or Balloon Kyphoplasty. Pflugmacher R, Bornemann R, Koch EM, Randau TM, Müller-Brioch J, Lehmann U, Weber O, Wirtz DC, Kabir K. Z Orthop Unfall. 2012; 150:56-61.

Preferential cavity creation, controlled delivery, and consistent RF modulated ultra-high viscosity bone cement help minimize the potential for extravasation.

What are the advantages?

The radiofrequency kyphoplasty is conducted with the StabiliT Vertebral Augmentation System, which excels through:

Bendable cannula allows creation of small bone cavities as cement storage.

Unipedicular access

  • Radiofrequency applicator to deliver ultra-highly viscous cement
  • Extended application time up to 30 min
  • Remote control with start-stop function
  • Treatment of multiple levels with only one kit
  • Easy handling