Caution-Investigational Device - Limited by United States Law to Investigational Use.
Background
Breast cancer is the second most common cancer (after lung cancer) and the fifth most common cause of cancer death. The current standard for breast cancer treatment is surgery (lumpectomy, mastectomy). Other means of treating breast cancer include chemotherapy, radiotherapy and immune therapy, depending on the level of risk.
ExAblate using MR guided focused ultrasound has the potential to provide a non-invasive outpatient treatment for breast cancer tumors without the need for an incision.
Using ExAblate for treating breast cancer
The ExAblate OR breast module is being investigated (outside of the USA) and is currently under FDA investigational review for the treatment of breast cancer. The desired result is total non-invasive ablation of the tumor verified by MR images.
ExAblate may offer the following potential benefits:
- Non-invasive alternative to surgical lumpectomy
- Definition of tumor boundaries by multi-parametric MR imaging
- No general anesthesia, surgery, surgical scar, or need for breast reconstruction
To date, over two hundred breast cancer patients have been treated in various clinical trials. In one series, patients were treated with ExAblate and then underwent a lumpectomy. Assessment of the resected specimen showed an average necrosis of 97% with 50% of the patients achieving 100% necrosis*. These patients then continued their treatment regimen according to the standard of care.
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