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 in nearly 25,000 vertebrae in over 17,000 cases. The continued success of this innovative procedure is increasingly making it the choice of physicians everywhere.

Clinically demonstrated, 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.  See DFINE bibliography.
 

Reduced extravasation

Significant pain reduction



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



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 level 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



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.3

  • 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 old
  • Cement leakage with RF-TVA averaged 10.6%, but only 11.6% when delivered into fractures greater than six weeks old



Significantly reduced pain and disability




  •  65 patients were treated with conservative care
  • After six weeks of conservative care, improvement in pain scores (by Visual Analogue Scale - VAS) and function scores (by Oswestry Disability Index - ODI) were 0 points and 6 points respectively
  • 33 patients chose to cross over to surgery
  • Six weeks after surgery, improvement in median pain scores (VAS) and function scores (ODI) were 5 points and 38 percent respectively4
  • For the vast majority of patients with a VAS ≥ 5, conservative care did not provide meaningful clinical improvement. In contrast, nearly all patients who underwent radiofrequency kyphoplasty (RF-TVA) had rapid substantial improvement


Reduced pain and risk of cement extravasation



  • At six months, 103 RF-TVA patients were examined and 91 balloon kyphoplasty patients were examined5 


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

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

  • 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 months



Percent of patients with pain relief 

93% of patients had complete or moderate pain relief.7

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



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:

  • 66 RF-TVA procedures were performed
  • A standard 10-point visual analogue 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 months.8


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. Georgy, B.  "Comparison Between RF Kyphoplasty, balloon kyphoplasty and high viscosity vertebroplasty in treatment of spinal compression fractures."  The 2nd Joint Meeting Of European Society of Neuroradiology (ESNR) & American Society of Spine Radiology (ASSR).  2011.
  3. 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.
  4. Bornemann R, Hanna M, Kabir K, Goost H, Wirtz C, Pflugmacher R.  "Continuing conservative care versus crossover to radiofrequency kyphoplasty: a comparitive effectiveness study on the treatment of vertebral body fractures."  European Spine Journal DOI: 10.1007/s00586-012-2148-8 Online FirstTM Springer-Verlag 2012.
  5. Pflugmacher R, Bornemann R, Koch E, Randau T, Muller-Broich J, Lehmann U, Weber O, Wirtz C, Kabir K.  "Comparison of clinical and radiological data in the treatment of patient with osteoporotic vertebral compression fractures using radiofrequency kyphoplasty or balloon kyphoplasty."  und Poliklinik fur Orthopadie und Unfallchirurgie, Universitatsklinjkum, Bonn. Z Orthop Unfall 2012; 150:56-61.
  6. Pflugmacher R, Randau T, Kabir K, and Wirtz DC. Radiofrequency (RF) Kyphoplasty in treatment of osteolytic vertebral fractures. IOF WCO-ECCEO10 2010.
  7. 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.
  8. Erdem, E. "Radiofrequency Kyphoplasty (RFK) for the Treatment of Vertebral Compression Fractures As a Result of Multiple Myeloma."  ASSR 2011.