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

Fracture morphology, cement viscosity, and the method of injection
Recent data suggests that fracture morphology, cement viscosity, and the method of injection may influence the likelihood of cement extravasation during vertebral augmentation.1 RF-TVA and the StabiliT System work together to provide greater physician control during bone cement delivery and to minimize cement extravasation.

RF-TVA with StabiliT® ER2 Bone Cement


StabiliT® ER2 Bone Cement viscosity range.
 

RF-TVA™ with the StabiliT System utilizes StabiliT® ER2 Bone Cement, a proprietary energy-responsive bone cement. When heated by RF energy, StabiliT® ER2 Bone Cement becomes an ultra-high viscosity cement that allows an ultra-high viscosity cement to be delivered over an extended working time beyond that of standard PMMA bone cements.
 


StabiliT® ER2 Bone Cement quickly reaches and stabilizes at an ultra-high viscosity for an extended period of time. RF-heated StabiliT® ER2 Bone Cement is an ultra-high viscosity bone cement.
 

Significant reduction in extravasation

Use of StabiliT® ER2 Bone Cement with RF-TVA significantly decreases the incidence of cement extravasation.2

  •  39 levels were treated with RF-TVA
  • 66 levels were treated with high-viscosity vertebroplasty 
  • 49 levels were treated with conventional balloon kyphoplasty 
  • No leakage was reported in 69% of the RF-TVA group, compared to 53% in the vertebroplasty procedure group and 41% in the conventional balloon kyphoplasty procedure group2
  • This represents a significant decrease in incidence of cement leakage when using RF-TVA:
    • 34% lower leakage rate than vertebroplasty2
    • 47% lower leakage rate than conventional balloon kyphoplasty2


Consistent interdigitation throughout the vertebra


Ultra-high viscosity StabiliT® ER2 Bone Cement provides consistent interdigitation throughout the vertebra
 


StabiliT® ER2 Bone Cement flowing into a 1 mm hole as it happens.
 

Significant pain reduction

StabiliT® ER2 Bone Cement fills the pathways created by the VertecoR MidLine Osteotome to ensure targeted delivery and interdigitation throughout the vertebra, potentially resulting in a safer and more effective vertebral augmentation.

  • 66 RF-TVA procedures were performed between December 2008 and May 2009
  • A standard 10-point visual analog scale (VAS) was utilized to assess back pain pre- and post-operatively
  • Pain medication use and activities were defined and monitored for changes
  • Significant improvement in pain, activity, and narcotic use was observed at 6 months3

Reduced radiation exposure

StabiliT® ER2 Bone Cement can be remotely dispensed to minimize radiation exposure.

RF-TVA with the StabiliT System allows StabilitT ER2 Bone Cement 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.