|The StabiliT® System combines a targeted approach and ultra-high viscosity cement to treat pathological fractures and minimize extravasation in the vertebrae.|
Preferential cavity creation, controlled delivery, and consistent RF modulated ultra-high viscosity bone cement help minimize the potential for extravasation.1
The articulating PowerCURVE® Osteotome minimizes the destruction of intact cancellous bone and maximizes interdigitation for optimally filled and mechanically sound vertebrae.2
The StabiliT® system allows users to stand up to 20 feet away from x-ray sources and reduce radiation exposure.
- Pflugmacher R, Bornemann R, Koch EM, Randau TM, Muller-Broich J, Lehmann U, Weber O, Wirtz DC, Kabir K. Comparison of Clinical and Radiological Data in the Treatment of Patients with Osteoporotic Vertebral Compression Fractures using Radiofrequency Kyphoplasty or Balloon Kyphoplasty. Z Orthop Unfall. 2012 Feb;150(1):56-61 PubMed: 21993914
- Dalton, B. E., Kohm AC, Miller LE, Block JE, Poser RD. Radiofrequency-targeted vertebral augmentation versus traditional balloon kyphoplasty: radiographic and morphologic outcomes of an ex vivo biomechanical pilot study. Clinical Interventions in Aging. 2012 7:525-31 PubMed: 23204845
Indications for Use
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 vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Risks and Contraindications
As with most surgical procedures, there are risks associated with the StabiliT® procedure, including serious complications. For complete information regarding risks, contraindications, warnings, and precautions, please review the systems’ Instruction for Use. For complete information regarding System related adverse events please see Instructions for Use.