RF-TVA with the StabiliT System: Clinical Results

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 with the StabiliT System on more than 20,000 vertebrae in over 16,000 patients. The continued success of this innovative procedure is increasingly making it the preferred choice of physicians everywhere.

RF-TVA with the StabiliT System has provided significant back pain relief to patients after undergoing vertebral augmentation (see results below), and it has been the subject of more than 30 published articles, peer reviewed papers, meeting abstracts, and book chapters worldwide.

RF-TVA with the StabiliT® 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 with 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 with the StabiliT System provides greater physician control during bone cement delivery to minimize cement extravasation.

Results

Significant pain reduction

Visual analog scale (VAS) median pain scores and Oswestry disability scores (ODI)

Pre- and post-RF-TVA VAS pain and Oswestry 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 Index (ODI) scores improved significantly post treatment and continued to maintain improved levels at 3 and 6 months. ³

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 significant pain relief (>50% reduction of pre-op score). ⁴
• 94% of procedures were unipedicular.
• 90% of patients had no extravasation. ⁴
• Extravasation was clinically insignificant. ⁴

Reduced extravasation
RF-TVA extravasation versus vertebroplasty extravasation¹

*Measured as a percentage of total patients treated. Two patients experienced cement pulmonary embolism.¹

• 60 patients underwent RF-TVA to treat 92 osteoporotic vertebral compression fractures. ¹
• 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 height. ¹

RF-TVA versus conventional balloon kyphoplasty extravasation

A comparison of leakage rates between spine fracture 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 old. ²
• Cement leakage with RF-TVA averaged 10.6%, but only 11.6% when delivered into fractures greater than 6 weeks old. ²

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.

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Source: http://www.spine-health.com/education-centers/stabilit-spinal-fracture-treatment-vertebral-augmentation/physicians/rf-tva

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