RF-TVA™: Clinically Proven Results

Overview

Radiofrequency-Targeted Vertebral Augmentation™ (RF-TVA™) with the StabiliT® Vertebral Augmentation System first debuted in Europe in 2006. Entry into the United States spine fracture treatment arena followed in 2008.

To date, thousands of physicians worldwide have performed RF-TVA (formerly RF Kyphoplasty) with the StabiliT System on more than 10,000 vertebrae in over 7,000 patients. The continued success of this innovative procedure is increasingly making it the choice of physicians everywhere.

Clinically proven to be safe and effective, RF-TVA with the StabiliT System has provided significant back pain relief to patients after undergoing vertebral augmentation.

RF-TVA with the StabiliT System clinical results have been the subject of more than 30 published articles, peer reviews, meeting abstracts, and book chapters worldwide.
 

Significant pain reduction

Visual analog scale (VAS) median pain scores versus Oswestry disability scores3

 Pre- and post-RF-TVA pain and disability scores at 3 and 6 months.3

  • 63 patients underwent RF-TVA to treat 116 osteolytic vertebral compression fractures
  • Median pain (VAS) and Oswestry (disability) scores improved significantly post treatment and continued to maintain improved levels at 3 and 6 months3

Percent of patients with pain relief 4

93% of patients had complete or moderate pain relief.4

  • 68 levels treated with RF-TVA
  • 93% of patients had complete or moderate pain relief (>50% reduction of pre-op score) 4
  • 94% of procedures were unipedicular
  • 90% of patients had no extravasation4
  • Extravasation was clinically insignificant4

 

Reduced extravasation

RF-TVA extravasation versus vertebroplasty extravasation1

  Patients Treated Total Fractures Treated Fractures with cement leakage Incidence of cement leakage Symptomatic cement leakage*
RF-TVA 60 92 5 5.4% 0.0%
Vertebroplasty 39 52 31 59.6% 5.1%
*Measured as a percentage of total patients treated. Two patients experienced vertebroplasty complications: cement pulmonary embolism.1

  • 60 patients underwent RF-TVA to treat 92 osteoporotic vertebral compression fractures1
  • 39 patients were treated for 52 spine fractures (control group)1
  • Patients that underwent RF-TVA experienced 54% fewer incidence of cement leakage and saw a restorative increase in height1

RF-TVA extravasation versus conventional balloon kyphoplasty complications

A comparison of leakage rates between spine fractures treatments <6 weeks old and those >6 weeks old.2

  •  138 patients underwent conventional balloon kyphoplasty to treat 203 vertebral compression fractures
  • 42 patients were treated with RF-TVA for 60 vertebral compression fractures
  • Cement leakage for patients treated with balloon kyphoplasty averaged 18.7%, but was significantly higher at 27.7% for fractures greater than 6 weeks old2
  • Cement leakage with RF-TVA averaged 10.6%, but only 11.6% when delivered into fractures greater than six weeks old2

 

 

References

  1. Pflugmacher R, Randau T, Kabir K, and Wirtz DC. Radiofrequency (RF) Kyphoplasty in comparison to in Vertebroplasty (VP) A prospective evaluation. IOF WCO-ECCEO10 2010.
  2. 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.
  3. Pflugmacher R, Randau T, Kabir K, and Wirtz DC. Radiofrequency (RF) Kyphoplasty in treatment of osteolytic vertebral fractures. IOF WCO-ECCEO10 2010.
  4. Sewall L, Smith S, and Vlahos A. Clinical Evaluation of Percutaneous Vertebral Augmentation Procedures using Radiofrequency Kyphoplasty in Treatment of 69 Vertebral Compression Fractures. ASBMR 2010.