DFINE is committed to building scientific evidence to support the use of our products. Our latest therapeutic medical device, the STAR™ Tumor Ablation System, received FDA 510(k) clearance in 2010, and the company will be starting a Prospective, Randomized, Multicenter Clinical Trial to Evaluate the STAR Tumor Ablation System versus Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumors in the spine. Data from the trial will be used to support regulatory applications.
The EU STAR Ablation Trial is the first prospective study to focus on the substantial palliative benefits of targeted tumor ablation and StabiliT cement augmentation in the interventional oncology arena involving the spine. This therapeutic approach combines DFINE’s core technologies – radiofrequency energy, navigational instrumentation, and ultra-high viscosity bone cement – to create an extension of our RF platform. It represents a major milestone for cancer patients and for DFINE.
Moving forward the company continues to invest in clinical studies to further improve the quality of life for patients suffering from metastatic and vertebral pathologies.
Physicians' insights on RF Ablation
STAR Tumor Ablation Procedure