DFINE has treated the first breast cancer patient using the Spinal Tumor Ablation with Radiofrequency (STAR) system, under the 'evaluation of combined RF ablation and cement delivery in painful tumors of the spine trial (AbCT trial).
The study aims to evaluate the safety and efficacy of targeted radiofrequency spinal tumor ablation and cement augmentation in patients with metastatic spinal tumors.
The STAR System incorporates a bipolar navigational instrument which offers control and enables the physician to overcome technical challenges.
The FDA-approved device also permits minimally invasive targeted tumor necrosis of metastatic spinal tumors.
DFINE CEO Kevin Mosher said this therapeutic approach combines the company’s technologies – radiofrequency energy, navigational instrumentation and ultra-high viscosity bone cement using DFINE’s compatible StabiliT Vertebral Augmentation System into an extension of their RF platform.
DFINE plans to use data from the AbCT Trial to file for CE mark certification in 2012.