Prev   -  

The StabiliT® System In Action During RF-TVA™

Radiofrequency-Targeted Vertebral Augmentation (RF-TVA™) (formerly RF kyphoplasty) with the StabiliT® Vertebral Augmentation System, uniquely addresses limitations of current therapies such as traditional vertebroplasty and conventional balloon kyphoplasty in the treatment of vertebral compression fractures. RF-TVA achieves targeted site- and size-specific cavity creation through a single access point by using the VertecoR® MidLine Osteotome. This device enables:

  • Unipedicular, bone sparing cavity creation
  • Creation of preferential paths for targeted delivery of ultra-high viscosity cement
  • Optimal surface area for interdigitation
  • Near and long term mechanical stability

Reduced radiation exposure

StabiliT® energy-responsive (ER) Bone Cements can be remotely delivered to minimize radiation exposure.

RF-TVA with the StabiliT System allows StabilitT ER Bone Cements to be injected in a controlled manner from a distance of up to 10 feet from the patient, thereby reducing exposure to harmful radiation, such as X-rays, during bone cement delivery.

 

Risks associated with RF-TVA.
As with most surgical procedures, serious adverse events can occur, some of which can be fatal. RF-TVA is designed to minimize these risks as much as possible. However, potential serious adverse events that can occur include:

  • Myocardial infarction (heart attack)
  • Pulmonary embolism (cement leakage that migrates to the lungs)
  • Cerebrovascular accident (stroke)
  • Cardiac arrest (heart stops beating)
  • Paralysis or muscle weakness
  • Death
A prescription is required. Consult your patients to determine if this procedure is right for them and to discuss other potential concerns, including their current physical condition, age of the fracture, a treatment timetable, and RF-TVA (RF Kyphoplasty) risks and complications.

References

  1. Lador R, Dreiangel N, Ben-Galim PJ, and Hipp JA. A pictorial classification atlas of cement extravasation with vertebral augmentation. Spine J. 2010;10(12):1118-1127.
  2. Georgy, B. Comparison between RF Kyphoplasty, balloon kyphoplasty and high viscosity vertebroplasty in treatment of spinal compression fracture.” The 2nd Joint Meeting of European Society of Neuroradiology (ESNR) & American Society of Spine Radiology (ASSR). 2011.
  -