ExAblate® 2000, InSightec's first product, integrates focused ultrasound thermal ablation with GE Healthcare’s MR imaging capabilities to provide a non-invasive method for destroying or ablating targeted tissue. During this outpatient procedure, the patient lies inside the MRI scanner, which provides three-dimensional images of the target and surrounding tissue, enabling precise guidance of the ultrasound waves. High intensity focused ultrasound waves are directed into the body at a specific tissue, and at the focal point, raise the temperature of the targeted tissue to 65° to 85° Celsius, destroying it. The thermal imaging capabilities of the MRI scanner provide real-time feedback on all aspects of the procedure which gives the physician a high degree of control over its therapeutic outcome. 

The device received the European CE mark and ISO 13485 and is commercially available in the US, Israel, Europe, and Asia. ExAblate received the European CE mark for treating pain palliation caused by bone metastases which represents the potential for expanding this non-invasive technology for oncology applications.

Excellence. Experience. ExAblate®.

First and only FDA approved focused ultrasound non-invasive therapeutic application

• Over 4 years experience post PMA using MR guided focused ultrasound
• Over 5000 women treated globally with improved symptom relief and patient satisfaction
• Non-invasive uterus-sparing procedure
• No anesthesia and no hospitalization required
• Improved quality of life for patients, back to normal activity the next day

Approved by the U.S. Food and Drug Administration in 2004 as an incisionless treatment alternative for symptomatic uterine fibroids, ongoing research is being conducted in oncology applications: pain palliation of bone metastases, prostate and breast cancer.

ExAblate® 2000 using non-invasive MR guided focused ultrasound

Uterine fibroids (also referred to as myomas, leiomyomas, leiomyomata, and fibromyomas) are benign (non-cancerous) tumors that grow within the muscle tissue of the uterus. They are the most common pelvic tumors in women, with a prevalence of 20-40% in women of reproductive age. Fibroids occur at a higher rate among women of African-American descent. While many women with fibroids do not experience any symptoms, the location and size of fibroids can change and cause symptoms that can affect a woman’s quality of life.

ExAblate using MR guided focused ultrasound for treating uterine fibroids

ExAblate 2000 is the first and only FDA approved focused ultrasound therapeutic application for uterine fibroids.

Magnetic Resonance guided Focused Ultrasound (MRgFUS) has been demonstrated as a viable option for effectively treating uterine fibroids. 

Compared to traditional hysterectomy, which is the primary treatment option for uterine fibroids, MRgFUS offers both clinical and economic advantages. Because it is a non-invasive procedure, patients avoid the risks associated with surgery, require only limited conscious sedation, and can return to normal activities the next day compared to lengthy recovery times and hospitalization days for the more traditional hysterectomy surgery. This translates into a significant economic impact for patients who undergo the MRgFUS procedure with documented fewer disability days (decreased days of missed work or days in bed) and lower use of medical resources: 83% fewer physician visits, 66% fewer additional diagnostic tests, and 66% fewer additional procedures.

Benefits of ExAblate for treating fibroids

• It’s a non-invasive outpatient procedure meaning patients do not require overnight hospital stays.
• Patients are able to go back to work the following day.
• Localized targeting and deposit of therapeutic energy is limited to the inside of the fibroid capsule.
• There are no treatment effects to the surrounding uterine tissue.
• The physician is able to see the effects of the treatment immediately after the procedure.
• Low incidence of complications
• No radiation exposure