SAN JOSE, Calif.–(BUSINESS WIRE)–April 17, 2013–
DFINE, Inc., the developer of minimally invasive radiofrequency (RF) targeted therapies for the treatment of vertebral pathologies, released results from two studies presented at the Society of Interventional Radiology’s Annual Scientific Meeting. Results from both studies underscore the benefits of advanced Targeted-Radiofrequency Ablation(TM) (t-RFA) therapy using the STAR(TM) Tumor Ablation System for the treatment of painful malignant lesions of the vertebral body.
The first presentation, titled “Image-guided targeted radiofrequency ablation (t-RFA) of spinal tumors using a novel bipolar navigational device: Multicenter initial clinical experience,” by Jack Jennings, M.D., Ph.D., Assistant Professor of Radiology and Director of Musculoskeletal and Spine Interventions at the Washington University School of Medicine at Washington University in St. Louis, noted that the STAR System provided a significant clinical advantage by allowing access to spinal lesions not typically accessible with traditional ablative devices, and in many cases permitting treatment of individual lesions not controlled by systemic or radiation therapy.Dr. Jennings and his co-authors treated 101 spinal lesions in 73 patients at six centers using the STAR System, followed by cement augmentation with high-viscosity bone cement in those vertebrae with pathologic fractures. Lesion etiology included a wide variety of metastatic tumors throughout the thoracolumbar and sacral spine. Cement augmentation post t-RFA proved to be efficient and resulted in predictable cement filling. Pain relief, measured by Visual Analogue Scale (VAS), was rapid, significant and durable measuring 7.35 pre-op, 2.47 at one week post-op, and 1.75 at 6 months post-op. Decrease in pain medication usage was recorded post procedure and no complications or thermal injury were observed.
“The STAR System is a highly effective tool capable of providing rapid pain relief from metastatic vertebral body tumors,” Dr. Jennings said. “We have found it to be particularly valuable when managing patients whose spinal tumors were unresponsive to traditional radiation and chemotherapy treatments. Now we can easily treat them using t-RFA without significant interruption to their primary cancer treatment regimen.”In the second study, Robert Ryu, M.D., Professor of Radiology of the Feinberg School of Medicine at Northwestern University and his co-authors used the STAR System to treat 13 lesions in 11 patients that failed conventional chemotherapy and radiation therapy, followed by injection of high-viscosity bone cement into the ablated tumor bed. All patients noted clinically significant pain relief, with a decrease in average VAS score from 8.9 pre-procedure to 2.7 four days after treatment. No treatment-related complications occurred during the follow-up period. These data are consistent with the large multicenter experience (Jennings et al), demonstrating palliative treatment alternatives for painful spinal metastatic lesions.
“The data presented at SIR by leading clinicians reinforces previous evidence supporting the use of DFINE’s STAR Tumor Ablation System for the treatment of painful metastatic spinal tumors,” said Kevin Mosher, Chief Executive Officer of DFINE. “We are very excited to share this data and even more pleased to offer the many patients affected with spinal tumors a new treatment option.”
About DFINE, Inc.
DFINE is dedicated to relieving pain and improving the quality of life for patients suffering from vertebral pathologies through innovative, minimally invasive, targeted therapies. The company’s devices are built on an extensible radiofrequency (RF) platform that currently covers two procedural applications: 1. The treatment of vertebral compression fractures (VCFs) with the StabiliT(R) Vertebral Augmentation System, and 2. The palliative treatment of metastatic vertebral body lesions with the STAR(TM) Tumor Ablation System. Both systems represent generational advancements in the minimally invasive treatment of vertebral pathologies. DFINE is based in San Jose, Calif. and is a privately held company. Stay connected with DFINE via Facebook or Twitter (@DFINEinc).
DFINE STAR Demonstrates Significant Clinical Benefit for Spinal Metastases
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