Healthcare Industry News: Vertebral Augmentation
News Release - January 22, 2013
Physicians Report Successful Clinical Use of the DFINE STAR(TM) Tumor Ablation System in Malignant Lesions of the SpineSAN JOSE, Calif.--(Healthcare Sales & Marketing Network)--DFINE, Inc., the developer of minimally invasive radiofrequency (RF) targeted therapies for the treatment of vertebral pathologies, today announced results of a multicenter clinical experience with Targeted Radiofrequency Ablation™ (t-RFA) therapy for malignant lesions of the spine using the DFINE STAR™ Tumor Ablation System. The STAR System enables physicians to provide patients with rapid pain relief from metastatic vertebral body spinal tumors in a single, minimally invasive treatment.
A poster, entitled "Targeted Radiofrequency Ablation of Spinal Tumors Using a Novel Bipolar Navigational Device: Initial Multicenter Clinical Experience,” was presented at the 2013 Symposium on Clinical Interventional Oncology (CIO) in Miami on Saturday, Jan. 19 by Jack Jennings, M.D., Ph.D., Assistant Professor of Radiology at the Washington University School of Medicine, on behalf of the Phase I group of STAR physicians.
Seventy-eight spinal lesions in 55 patients were treated at four U.S. academic centers. The STAR System was reported to successfully navigate the unique anatomy of the spine to ablate malignant lesions. Post-ablation MRIs confirmed lesions were included in the ablation zone and that lesion necrosis occurred. In many cases, this technique allowed for the treatment of individual lesions not controlled by systemic or radiation therapy. In vertebral bodies with pathologic fractures, or in certain cases where physicians determined the vertebra was at risk of fracture, high viscosity cement was delivered following ablation via the same working cannula.
No complications or thermal injury occurred. Post-procedural pain levels were diminished and disability levels improved.
“The navigational ability of the STAR System allowed for easy access to posterior vertebral body lesions, which previously have been difficult to access with other ablation devices,” Jennings noted. In addition, we noticed a substantial reduction in patients’ pain and disability level from pre to post procedure.”
The complete abstract can be accessed via the following link: http://www.eventscribe.com/2013/posters/isetcio/ SplitViewer.asp?PID=MTExODA5NDc2.
“We are extremely pleased with the latest clinical results. We believe the STAR System can offer more rapid pain relief without interrupting systemic therapy, and these data add to the growing body of evidence in support of t-RFA as a viable therapy for patients suffering from painful metastatic spinal tumors,” said Kevin Mosher, Chief Executive Officer of DFINE.
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.
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