Two studies presented at the Society of Interventional Radiology’s 37th Annual Scientific Meeting in San Francisco, USA (24–29 March 2012) highlight the clinical benefits of treatment with radiofrequency targeted vertebral augmentation therapy (RF-TVA) with the StabiliT Vertebral Augmentation System (DFine) to repair vertebral compression fractures resulting from instability due to osteoporosis or cancer.
The first study titled: “Radiofrequency targeted vertebral augmentation (RF-TVA) for osteoporotic compression fractures,” presented by Frank Moser, director, Clinical Neuroradiology and Interventional Neuroradiology, Cedars-Sinai Medical Center, Los Angeles USA, concluded that RF-TVA is a safe and effective method for treatment of vertebral compression fractures.
“The use of RF energy, to warm cement immediately prior to entering the patient, resulted in the unique combination of consistently high viscosity cement that was useable over an extended working time,” said Moser, lead author of the study. “In addition, we noticed a substantial reduction in patients’ pain from pre-procedure to discharge. Most notably, we saw a marked improvement in average Oswestry Disability Index (ODI) scores (34.14%, p<0.0001).”
The study enrolled 20 patients aged between 50–90 years, from May 2009 to January 2011, with 1-3 painful vertebral compression fractures (confirmed by MRI and pain concordant with index level). The results show no procedure related complications and none of the patients required bilateral procedures.
A second study: “Comparative analysis of cement extravasation in radiofrequency targeted vertebral augmentation, balloon kyphoplasty and high viscosity cement vertebroplasty,” presented by Bassem Georgy, assistant clinical Professor of Radiology in the Department of Radiology at the University of California at San Diego/Thornton Hospital, La Jolla, USA, concluded that targeted cement augmentation using the RF-TVA technique may provide up to a 50% reduction in leakage when compared to conventional balloon kyphoplasty as well as vertebroplasty, even when performed with high viscosity cement.
“In addition to a significant reduction in cement leakage, we noted that StabiliT’s uni-pedicular access and remote-controlled cement delivery further decreased procedural invasiveness and physician radiation exposure,” said Georgy, lead author of the study.
The study compared, in a retrospective analysis of postoperative radiographs of 112 vertebral compression fracture patients, the incidence and pattern of cement leakage in 159 treated levels with either high-viscosity cement vertebroplasty (DePuy) (66 levels), standard balloon kyphoplasty (Medtronic) (46 levels) and radiofrequency targeted vertebral augmentation (StabiliT System, DFine) (47 levels).
The results show 33 leakages in the vertebroplasty group (17 discal, 11 venous, 4 paravaertebral and 1 epidural). In the balloon kyphoplasty group 31 leakages were observed (15 discal, 11 venous, 3 paravaertebral and 2 epidural). Sixteen leakages were observed in the RF-TVA group (8 discal, 5 venous, 3 paravaertebral and non epidural). All leakages were asymptomatic.
“Despite advancements in existing vertebral compression fracture treatments, physicians continue to demand a treatment option that is not only minimally invasive, but also provides control, accuracy and predicative results. DFine’s technology fills that need, and offers a generational advance in the treatment of spine fractures,” said Kevin Mosher, CEO, DFine, “The data presented at SIR’s Annual Scientific Meeting add to the growing body of evidence that demonstrates our intent to reduce cement leakage risk, and illustrates the clinical utility of RF-TVA, highlighting the advantages of the StabiliT System over other options.”
