SAN JOSE, Calif. -- (BUSINESS WIRE) -- DFINE, Inc., the developer of minimally invasive radiofrequency (RF) targeted therapies for the treatment of vertebral pathologies, today released data presented at the 2013 Annual Symposium of the American Society of Spine Radiology (ASSR) on Feb. 22, 2013. Results from the study reinforce earlier clinical reports of t-RFA using the STAR™ Tumor Ablation System for the treatment of malignant lesions of the spine.
The presentation, titled "Targeted Radiofrequency Ablation of Malignant Spine Lesions Before Cement Augmentation Using Novel Bipolar Navigational Device,” by Bassem Georgy, M.D., Assistant Clinical Professor of Radiology at the University of California, San Diego, noted improved pain and functional status in all patients following treatment using the STAR System.
Dr. Georgy treated 34 spinal lesions in 22 patients with varied malignancies using t-RFA. Cases were followed by augmentation with high-viscosity cement in vertebral bodies with pathologic fractures, or in cases where the structural integrity of the vertebra was significantly compromised. The STAR System permitted minimally invasive access to all spinal lesions, regardless of location. Post-ablation MRI and PET scans showed decreased tumor volume and metabolic activity, respectively.
Additionally, clinically significant pain relief (>30% change) was reported, with decrease in average VAS score from 7.1 pre-procedure to 4.75 post-procedure. Function, as assessed by ODI scores, improved from 25.6 to 18.5 post-procedure, which represents improvement from a moderate to minimal disability level. All procedures were performed safely with no complications or thermal injury.
“The STAR System provides an entirely new tool to deliver rapid pain relief from metastatic vertebral body tumors in a single, minimally invasive treatment,” Georgy said. “Not only does this result in a restoration of quality of life for my patients, there is minimal delay to their primary cancer treatment.”
“Presentation of this data by leading clinicians adds to the growing body of evidence supporting the use of DFINE’s radiofrequency targeted therapies for the treatment of vertebral pathologies,” said Kevin Mosher, Chief Executive Officer of DFINE. “We are extremely pleased to provide innovative new treatment options for the many patients suffering from painful metastatic tumors of the vertebral body.
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® Vertebral Augmentation System, and 2. The palliative treatment of metastatic vertebral body lesions with the STAR™ 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) or call 1.866.963.3463.