ExAblateŽ 2000 is a noninvasive treatment for uterine fibroids that has been newly approved by the FDA. 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.

close

Magnetic Resonance guided Focused Ultrasound. 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.

close

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.

close

The treatment typically takes three to four hours, depending on the size of the targeted fibroid.

close

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.

close

While the tumors that were treated will not re-grow, new or untreated fibroids may continue to grow.

close

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.

close

While the procedure is performed by interventional radiologists, patient care through the entire process is a joint effort between OB/GYNs and interventional radiologists.

close

For a full listing of the treatment alternatives to MRgFUS, please refer to the Treatment Options Grid included in the press kit.

close

University MRI, Boca Raton, FL
Brigham and Women's Hospital, Boston, MS
Johns Hopkins Hospital, Baltimore, MD
Mayo Clinic, Rochester, MN
Tower Beverly Radiology - Radnet, Beverly Hills, CA
Virtua Health. Marlton, NJ
The Lahey Clinic, Boston, MA

close

With FDA approval, InSightec expects many facilities to add ExAblate as a treatment option for symptomatic uterine fibroids.

close

Clinical trials to verify the safety and efficacy of MRgFUS in breast fibroadenomas and breast cancer are currently underway. In the future, InSightec will explore additional applications, including treatment for brain tumors, and cancers of the liver, bone and prostate.

close