Xoft brain IORT is a promising treatment option that may offer better outcomes for patients, with minimal side effects, compared to traditional radiation therapy. For the treatment of certain types of brain tumors, IORT with the Xoft System may allow appropriately selected patients to potentially replace weeks of post-operative external beam radiation therapy (EBRT) with a single fraction of radiation. IORT with the Xoft System allows radiation oncologists and surgeons to work together to deliver a full course of radiation treatment in one day, at the time of surgery, while the patient is under anesthesia. Once the tumor has been surgically removed, the Xoft System’s miniature x-ray source is inserted inside a flexible balloon-shaped applicator, which is then placed inside the tumor cavity, filled with saline, and used to deliver a single dose of radiation directly to the tumor bed.
Description
Description.
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1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm. Accessed 1-19-22. FDA 510K submissions K182373, K201019, K193229.
2. Conant, E et al. (2019). Improving Accuracy and Efficiency with Concurrent Use of Artificial Intelligence for Digital Breast Tomosynthesis. Radiology: Artificial Intelligence. 1 (4). Accessed via https://pubs.rsna.org/doi/10.1148/ryai.2019180096
3. Based on publicly available data as of September 2021. For GE and Hologic only. Uses 2D synthesized images.
4. iCAD data on file.