• MR imaging allows physician to identify the fibroid(s) and surrounding anatomy
• Ultrasound energy is focused to a small volume within the tumor (~ 1x3 cm)
• Heat from the ultrasound energy destroys (ablates) the tissue in ~ 20 seconds
• The process is repeated as many times as necessary until tumor is destroyed
• The body disposes of destroyed tissue as part of normal function

Clinical Efficacy
A recent clinical trial showed that 70.6 percent of women treated reported a significant improvement in fibroid-related symptoms at six months post-treatment. The study compared the results of ExAblate treatment with total abdominal hysterectomy. Patients treated with ExAblate missed 1.4 working days, on average, compared to an average of 18 days for the hysterectomy group. They returned to normal activity in less than 3 days, compared to 17 days for the hysterectomy group.

When is it used?
The ExAblate® 2000 is intended for use in women who:

• Have symptomatic uterine fibroids
• Are pre- or peri-menopausal
• Desire a uterine sparing treatment
• Have a uterine volume of less than 24 weeks
• Have completed child bearing

When should it not be used?
The  ExAblate® 2000 treatment is contraindicated for use in women who have:

• MRI related issues, such as metallic implants, or sensitivity to MRI contrast agents
• Obstructions in the treatment beam path, such as a scar, skin fold or irregularity, bowel, pubic bone, IUD (intrauterine device)surgical slips, or any hard implants
• Fibroids pedunculated, or those that are close to sensitive organs such as the bowel or
  bladder, or are outside the image area.

What is ExAblate® 2000?
ExAblate® 2000 is a non-invasive treatment for uterine fibroids approved by the FDA in October 2004. The technology 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.

What is MRgFUS?
Magnetic Resonance guided Focused Ultrasound. During this outpatient procedure, the patient lies inside the MRI scanner. Th e 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 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 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 fi nd 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.

Do uterine fibroids return after the treatment?
While the tumors that were treated will not re-grow, new or untreated fibroids may continue to grow.

Are there risks associated with this procedure?
As with any medical procedure, there are risks involved with the ExAblate 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 ExAblate treatment?
While the procedure is performed by interventional radiologists, patient care through the entire process is a joint effort between OB/GYNs and interventional radiologists.