Clinical studies

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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* Reference
Furusawa H, Namba K, Thomasen S, Akiyama F, Bendet A, Tanaka C, Yasuda Y, Nakahara H. Magnetic Resonance-Guided Focused Ultrasound Surgery of Breast Cancer: Reliability and Effectiveness, J Am Coll Surg, 2006, 203(1):54-63. 

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Clinical studies