How StabiliT Works


RF-TVA with the StabiliT System is typically an outpatient procedure that usually requires only local anesthesia and a small incision to access the vertebra. The entire procedure takes about 30 to 40 minutes.

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Step 1) The VertecoR(R) MidLine Navigational Osteotome is used to enter the fractured vertebra.

StabiliT

Step 2) A small space is created within the vertebra to later fill with ultra-high viscosity bone cement.

StabiliT

Step 3) The bone cement is delivered slowly, allowing it to penetrate into the vertebra to fill the small space, and to minimize the likelihood of complications. The MultiPlex Controller allows the physician to remotely deliver the bone cement, potentially decreasing physician radiation exposure. The bone cement hardens within minutes with subsequent fracture stabilization.

StabiliT

A small band-aid is placed over the incision following the treatment. The patient will then spend several hours in the recovery room, prior to returning home. As patients begin their recovery, they can expect to feel rapid and lasting back pain relief.1-6

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The StabiliT(R) Vertebral Augmentation System is intended for percutaneous delivery of StabiliT(R) Bone Cement in vertebral augmentation (kyphoplasty) procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

As with most surgical procedures, kyphoplasty procedures using the StabiliT System (also called Radiofrequency-Targeted Vertebral Augmentation, or RF-TVA) involve risks, some of which may be serious or even fatal. Patients undergoing RF-TVA are subject to risks associated with surgery including, but not limited to, complications from anesthesia/sedation as well as bleeding, bruising, pain, infection, blood clots, myocardial infarction, cardiac arrest, stroke, pulmonary embolism, as well as damage to normal tissue, nerves, the spinal cord or other structures, which could result in injuries, including paralysis. Not every patient is a good candidate for RF-TVA. The StabiliT System is contraindicated for patients with coagulation disorders, severe pulmonary insufficiency, and certain spinal conditions, or patients who are sensitive to components of StabiliT Bone Cement.

References:

  1. Murphy K. Radiofrequency Kyphoplasty: A Novel Approach to Minimally Invasive Treatment of Vertebral Compression Fractures in The Comprehensive Treatment of the Aging Spine: Minimally Invasive and Advanced Techniques edited by Yue JJ, Guyer R, Johnson JP, Khoo LT, Hochschuler H, and Hochschuler SH. Elsevier. Pg 248-252.
  2. Elgeti F and Gebauer B. Radiofrequency Kyphoplasty for the Treatment of Osteoporotic and Neoplastic Vertebral Body Fractures: Preliminary Experience and Clinical Results after 6 Months. J Miner Stoffwechs. 2011;18 Suppl 1:S5-9.
  3. Licht AW and Kramer W. Radiofrequency kyphoplasty: a new method for the treatment of osteoporotic vertebral body compression fractures not– a case report. J Miner Stoffwechs. 2011;18 Suppl 1:S26-28.
  4. Licht, AW and Kramer W. One-year observation study upon a new augmentation procedure (Radiofrequency-Kyphoplasty) in the treatment of vertebral body compression fractures. Eurospine 2011.
  5. Erdem E, Akdol S, Amole A, Fryar K, and Eberle R. Initial Clinical Experience with Radio-Frequency Based Vertebral Augmentation in Treatment of Vertebral Compression Fractures As a Result of Multiple Myeloma. ASSR 2011.
  6. Pflugmacher, R, Bornemann, R, Randau, T, and Wirtz, DC. Comparison of clinical and radiological data in treatment of patients with osteoporotic vertebral compression fractures with radiofrequency kyphoplasty or balloon kyphoplasty. GRIBOI 2011 – The 21st Interdisciplinary Research Conference On Injectable Osteoarticular Biomaterials and Bone Augmentation Procedures.
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