Treatment of Metastatic Spinal Lesions with a Navigational Bipolar Radiofrequency Ablation Device: A Multicenter Retrospective Study

Praveen R. Anchala, MD, Winston D. Irving, MD, Travis J. Hillen, MD, Michael V. Friedman, MD, Bassem A. Georgy, MD, Douglass, M. Coldwell, MD, PhD, Nam D. Tran, MD, PhD, Frank D. Vrionis MD, PhD, Allan Brook, MD, and Jack W. Jennings, MD, PhD

Article presented the reality of fast and lasting relief from painful metastatic lesions

Praveen study 1

Conclusions

The STAR Tumor Ablation System:

  • Was safely & effectively used in the treatment of metastatic spinal tumors
  • Allowed RFA treatment of previously untreatable lesions which resulted in reduction of pain that was not controlled with systemic or radiation therapy
  • In certain cases with posterior wall involvement, posterior extension of tumor was halted
  • Did not hinder or delay other therapies

Treatment of Metastatic Posterior Vertebral Body Osseous Tumors by Using a Targeted Bipolar Radiofrequency Ablation Device: Technical Note

Travis J. Hillen, MD, Praveen R. Anchala, MD, Michael V. Friedman, and Jack W. Jennings, MD, PhD. Hillen, et al., Radiology. 2014 June 13:131664, E-pub prior to print Pubmed ID: 24927327   This article presented how targeted Radiofrequency Ablation (t-RFA) with the STAR Tumor Ablation System can serve as a Minimally Invasive Solution to Safely and Effectively Treat Previously Inaccessible Spinal Lesions

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Conclusions

The STAR Tumor Ablation System:

  • Provides access to tumors that are difficult to reach with conventional ablation systems
  • Allows for safe & controlled ablation of spinal tumors
  • Does not hinder or delay other therapies
  • May provide an alternate therapy for tumors that do not respond to chemotherapy or radiation therapy

DFINE Announces Commencement Of Clinical Study On Spinal Tumor Ablation With The STAR Tumor Ablation System

San Jose, Calif. and Magdeburg, Germany – June 11, 2014DFINE®, Inc., a market leader in the minimally invasive treatment of spinal diseases, today announced that the first patient has been enrolled in the EU-STAR Clinical Trial. The multi-center trial is the first prospective study to evaluate clinical outcomes in patients receiving treatment with the STAR™ Tumor Ablation System for the palliative treatment of metastatic spinal tumors.

DFINE will enroll 40 patients at five centers in Germany and France. The trial will evaluate pain relief at one month as a primary outcome measure with follow up through six months. Secondary outcome measures include change in function, quality of life and pain medications post-procedure.

“We’ve had very promising results with targeted RF ablation (t-RFA™) to ‘melt’ the tumor followed by RF targeted vertebral augmentation™ (RF-TVA) during the same procedure to repair the damaged vertebrae,” said Dr. Boris Joellenbeck, a principal investigator at The Otto-von-Guericke University Magdeburg in Germany, where the first patient was treated. “Immediately following the procedure, the patient had a significant reduction in pain and increased activity level. We are excited about the many potential benefits of this therapeutic approach for our patients.”

Cancer is a major public health problem throughout the world, with more than 3.4 million new diagnoses each year in Europe alone.1 When cancer is not found early, it can metastasize (spread) to other parts of the body. A spinal tumor is a growth of cells (mass) in or around the vertebra near the spinal cord. It is estimated that 30-40 percent of cancer patients will likely develop metastatic spinal tumors.Many of these tumors also result in fractures of the vertebrae.

“t-RFA and RF-TVA provide an innovative new treatment option for the many patients worldwide who suffer from the debilitating effects of spinal tumors,” said Greg Barrett, Chief Executive Officer of DFINE. “As a company we are committed to building a body of scientific evidence supporting the therapy and are excited to partner with several leading medical centers in Germany and France on this landmark trial.”

To learn more about the EU-STAR clinical trial (ID # NCT02081053), interested parties may contact the study research staff found here: http://www.clinicaltrials.gov/ct2/show/NCT02081053 

About STAR™ Tumor Ablation System

t-RFA with the STAR System does not treat cancer. It is cleared by the FDA for providing palliative treatment (e.g. pain relief) by ablation of metastatic malignant tumors in a vertebral body. For a complete list of indications, risks and contraindications, visit http://www.dfineinc.com/Product-Risk—SpineSTAR

About DFINE, Inc.

DFINE is dedicated to relieving pain and improving the quality of life for patients suffering from spinal diseases through innovative, minimally invasive therapies. The company’s flagship products, the StabiliT® Vertebral Augmentation System and STAR™ Tumor Ablation System, represent generational advancements in the minimally invasive treatment of spinal diseases. DFINE is based in San Jose, Calif. and is a privately held company.

DFINE and StabiliT are registered trademarks and STAR and Targeted Radiofrequency Ablation (t-RFA) are trademarks of DFINE, Inc. [media-contact]

Comparison of Radiofrequency-targeted Vertebral Augmentation with Balloon Kyphoplasty for the Treatment of Vertebral Compression Fractures: 2-year Results.

Bornemann R, Jansen TR, Kabir K, Pennekamp PH, Stüwe B, Wirtz DC, Pflugmacher R. J Spinal Disord Tech. 2013 Pubmed PMID: 24247030 OBJECTIVES:

Evaluation of safety and effectiveness of radiofrequency-targeted vertebral, augmentation (RF-TVA) in comparison to balloon kyphoplasty (BK) for the treatment of, acute painful vertebral compression fractures (VCF) on the basis of matched pairs.

METHODS:

A total of 192 patients (116 females; 51 – 90 y) with VCF (n=303) at one to three, levels were treated with RF-TVA or BK. Functionality (ODI), pain (VAS), vertebral, height (anterior, middle) and kyphotic angle were evaluated over a two year period, (postoperatively, 3-4 d, 3, 6, 12 and 24 mo). Additionally, operating time and, occurrence of cement leakage were recorded.

RESULTS:

Pain and functionality were significantly improved after both treatments. In both groups, there was an increase in vertebral height and a decrease in kyphotic angle, which, remained relatively consistent during 24 months. The incidence of cement leakage was, 9.4% (n=9) in the RF-TVA group and 24.0% (n=25) in the BK group. The mean, operating time with radiofrequency kyphoplasty was 25.9±9.9 minutes and with balloon, kyphoplasty 48.0±18.4 minutes.

CONCLUSION:

RF-TVA is a safe and effective procedure for the treatment of vertebral compression, fractures when compared to BK. Improvement in pain and functional scores following, RF-TVA are durable through 24 months post-procedure and remained better than, those following BK at long term follow up. Operating time for RF-TVA is shorter and the, risk of cement leakage is lower. Both procedures provided similar results in vertebral, height restoration and reduction in kyphotic angle.

Radiofrequency-targeted vertebral augmentation for the treatment of vertebral compression fractures as a result of multiple myeloma.

Erdem E, Akdol S, Amole A, Fryar K, Eberle RW. Spine 2013. Pubmed ID: 23591655

STUDY DESIGN: A retrospective review of a consecutive population of patients treated with radiofrequency-targeted vertebral augmentation (RF-TVA) for malignant vertebral compression fractures (VCFs). To investigate the safety and efficacy of RF-TVA in patients with malignant VCFs.

SUMMARY OF BACKGROUND DATA: The use of polymethylmethacrylate (PMMA) in vertebroplasty and balloon kyphoplasty for patients with recalcitrant pain after acute VCFs is shown to be safe, successful in stabilizing the VCF, and effective for the relief of pain after osteoporotic and malignant VCFs. RF-TVA using targeted cavity creation and ultrahigh viscosity PMMA delivery with a long handling time was developed to address the potential adverse issues that arise with vertebroplasty and balloon kyphoplasty.

METHODS: Between December 2008 and May 2009, a consecutive series of 66 RF-TVA procedures were performed for VCF secondary to multiple myeloma. Pre- and postoperatively, a standard 10-point visual analogue scale was used to assess back pain. Pain medication use and activity categories were defined and monitored for changes before and after RF-TVA. All patients were followed for 6 months postoperatively.

RESULTS: At 6 months postoperatively, significant improvement in pain, activity, and narcotic use was observed. Overall change in pain VAS score was statistically significant at 6 months (p< 0.001) and 75% of patients had a 6-month VAS of less than 4.There were no pulmonary or neurological complications, and one patient had radiographic evidence of asymptomatic leakage of PMMA into the vertebral disc space.

CONCLUSION: Optimum safety and efficacy results in the treatment of malignant VCFs with a novel RF-TVA technique in which controlled delivery of an ultrahigh viscosity PMMA is used for fracture stabilization. The deposition of PMMA with RF-TVA is predictable and uniform, and can be performed without PMMA handling constraints that may be encountered with vertebroplasty and balloon kyphoplasty.

Continuing conservative care versus crossover to RF-TVA (radiofrequency kyphoplasty): a comparative effectiveness study on the treatment of vertebral body fractures.

Bornemann R, Hanna M, Kabir K, Goost H, Wirtz C, Pflugmacher R. Euro Spine J 2012. Pubmed PMID: 22234722

BACKGROUND: There is controversy about how to treat vertebral fractures. Conservative care is the default approach. The aims of this study were to compare RF-TVA to conservative care and assess the usual algorithm of starting all patients on conservative care for 6 weeks before offering RF-TVA.

METHODS: Elderly patients with painful osteoporotic vertebral compression fractures were all treated with 6 weeks of conservative care (analgesics, bracing, and physiotherapy). They were then offered the choice of continuing conservative care or crossing over to radiofrequency kyphoplasty, at 6 and 12 weeks. Clinical success was defined as: (1) VAS pain improvement ≥2, (2) final VAS pain ≤5, (3) no functional worsening on ODI.

RESULTS: After the initial 6 weeks of conservative care, only 1 of 65 patients met the criteria for clinical success, and median pain VAS improvement was 0. After 12 weeks of conservative care, only 5 of 38 patients met the criteria for clinical success, and median pain VAS improvement was 1. After RF-TVA, 31 of 33 patients met the criteria for clinical success, and median pain VAS improvement was 5. Median range improvement in function ODI score was 38 (range 22-56). Cement leakage was only seen in 3 of 56 (5%) levels operated.

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CONCLUSION: 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 RF-TVA had rapid substantial improvement. RF-TVA was more effective than conservative care.

Comparison of Clinical & Radiological Data in Treatment of Osteoporotic VCFs Using RF-TVA (RF Kyphoplasty) or Balloon Kyphoplasty

Pflugmacher R, Bornemann R, Koch E, Randau T, Muller-Broich J, Lehmann U, Weber O, Wirtz C, Kabir K. Z Orthop Unfall 2012. PubMed PMID:21993914

PURPOSE: Since the 1990s, balloon kyphoplasty has been proven as an effective method of treating patients with painful vertebral compression fractures (VCF). The RF-TVA is an innovative procedure available since 2009, for which an ultra-high viscosity cement is used. For the statistical comparison of the two methods of augmentation, the clinical and radiological data of 2 large patient groups were evaluated – a prospectively collected RF-TVA treated group and a matched pair BKP treated group.

MATERIALS AND METHODS: A prospective study of RF-TVA was performed between 2009 and September 2010 using the StabiliT® Vertebral Augmentation System. For the BKP group, patients with the same clinical and radiographic parameters as in the first group were evaluated (matched pairs). Clinical parameters for efficacy and safety were pain intensity using a visual analogue scale (VAS: 0 to 100 mm) and function using the Oswestry Disability Score (ODI: 0 to 100%). Height restoration in the middle and anterior parts of the treated vertebra and reduction in kyphosis after RF-TVA and after 6 months were evaluated. Cement extravasation and operation time were compared. To compare the data statistically, parametric and non-parametric tests were applied.

RESULTS: 114 patients were enrolled and treated in the RF-TVA group and 114 patients (matched pair) previously treated with BKP were selected. Prior to treatment 84 mm on the VAS were calculated in both groups. The decrease in VAS values (RF-TVA vs. BKP) immediately after surgery was 58.8 vs. 54.7 mm (p = 0.02), and 73.0 vs. 58.9 mm after 6 months (p < 0.001). Both groups had significant improvements in ODI function scores after 6 months without a statistically significant difference. In both groups, the middle part of the vertebral bodies was increased by an average of 3.1 mm. RF-TVA yielded a decrease in the average kyphosis angle of 4.4, the BKP resulted in about 3.8 degrees. Extravasation was significantly less in the RF-TVA treated group (6.1 % vs. 27.8%; p < 0.0001). The RF-TVA procedure was significantly shorter than BKP (28.2 vs. 49.6 min; p < 0.001).

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CONCLUSIONS: The RF-TVA has proven to be a clinically very effective procedure. No differences could be detected regarding improvement of functioning and the mean restoration of mid- and anterior vertebral height. RF-TVA offers the advantage of a statistically significant lower proportion of cement extrusion.