FDA oks DFine radiofrequency ablation system
DFine has received FDA clearance of its radiofrequency ablation system, a percutaneous radiofrequency ablation (RFA) device for metastatic spinal lesions.
The platform extension designed for palliative treatment can provide localized tumor necrosis of vertebral body lesions where metastatic disease has spread to the spine, resulting in severe pain and discomfort, according to the San Jose, Calif.-based company. The device allows for targeted ablation of metastatic lesions in any location within the vertebral body using a unipedicular approach for pain relief.
RFA has been utilized to debulk liver and kidney tumors, and several studies have suggested its efficacy in the treatment of osseous metastatic disease, DFine added.
The platform extension designed for palliative treatment can provide localized tumor necrosis of vertebral body lesions where metastatic disease has spread to the spine, resulting in severe pain and discomfort, according to the San Jose, Calif.-based company. The device allows for targeted ablation of metastatic lesions in any location within the vertebral body using a unipedicular approach for pain relief.
RFA has been utilized to debulk liver and kidney tumors, and several studies have suggested its efficacy in the treatment of osseous metastatic disease, DFine added.