FAQ - Magnetic Resonance Guided Focused Ultrasound (MRgFUS)

MRgFUS is an advanced, non-invasive treatment that uses highly focused ultrasound to ablate, or destroy, fibroid tumors. The device works with an MR scanner to enable the physician to determine the level of heating and to monitor the progress of treatment during and after the procedure.

During this outpatient procedure, the patient lies inside the MRI scanner. The MRI scanner provides three-dimensional images of the fibroid and surrounding tissue, enabling precise guidance of the ultrasound waves to the target tissue. Highly focused ultrasound waves are directed into the body, and at the focal point, the ultrasound waves raise the temperature of the tissue, leading to its destruction. The thermal imaging capabilities of the MRI scanner provide real-time feedback on the temperature achieved at the target tissue during treatment, helping to ensure therapy outcome control.

What is ExAblate® 2000?
ExAblate® 2000 is the name of the system used to deliver the MRgFUS treatment. It was developed by InSightec and approved by the FDA in October of 2004.

What does a patient feel during the procedure?

Patients remain conscious during the procedure so they may communicate with the physician; however, they do receive mild sedation, so they are not fully alert during the treatment. Many patients report a feeling of warmth or heat sensations in their abdomen during the procedure.

How long does the treatment last?
The treatment typically takes three to four hours, depending on the size of the targeted fibroid.

How long after the treatment until patients can return to normal activities?
Depending on initial symptoms, most patients find relief of their fibroid-related symptoms within three months, as shown by a clinical study conducted by InSightec. In a 109-patient clinical trial, women returned to normal activities on average in less than three days, missing only 1.4 work days.

Are there risks associated with the MRgFUS procedure?
As with any medical procedure, there are risks involved with the MRgFUS treatment. These risks include skin burns, back or leg pain, abdominal cramping, nausea, fever, vaginal discharge, and urinary tract infection. The incidence of these complications is relatively low. There is a risk that the treatment may not be or that the treatment may be successful in reducing the symptoms from the fibroids that are treated, but at a later time, more fibroids may grow and require treatment. This is true for all fibroid treatment alternatives, except hysterectomy.

Who performs the MRgFUS procedure?
An interventional radiologist performs the MRgFUS procedure. Patient care is a joint effort between the OB/GYN physicians and interventional radiologist.

Where is the treatment currently available?
University Image Guided Therapy Center
University MRI, Boca Raton, FL
3998 FAU Blvd - Suite 200
Boca Raton, FL 33431
Telephone: 561-826-1274

For additional locations please refer to the InSightec Website

Is the treatment covered by insurance?
Currently, MRgFUS is a self-pay treatment that is not covered by MEDICARE or insurance.

What clinical trials or research is being done using the MRgFUS technology?
African American uterine Fibroid, Breast Fibroadenomas and Breast Cancer. In the future clinical trials to verify the safety and efficacy of MRgFUS in breast fibroadenomas and breast cancer are currently underway. In the future, additional applications will be explored, including treatment for brain tumors, and cancers of the liver, bone and prostate.



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