The ExAblate System uses Magnetic Resonance-guided Focused Ultrasound to perform uterine procedures without incisions.
January 13, 2010
InSightec Ltd. announced today that Japan's Ministry of Health, Labor and Welfare (MHLW) has approved the company's ExAblate® MR-guided Focused Ultrasound (MRgFUS) system for the treatment of women with uterine fibroids. The ExAblate system received the CE Mark for uterine fibroids in October 2002 and US Food and Drug Administration (FDA) approval in 2004.
Using the ExAblate system, the physician uses the Magnetic Resonance Imaging (MRI) to visualize the patient's anatomy and then aims focused ultrasound waves at the targeted tissue to thermally ablate, or destroy it. The MRI allows the physician to monitor and continuously adjust the treatment in real time. The patient is consciously sedated to alleviate pain and minimize motion.
A growing body of evidence supports the system's safety and efficacy, including the results of a study published in the August 2007 edition of Obstetrics and Gynecology. The study showed that ExAblate offered women sustained relief from uterine fibroid symptoms for up to two years, with a low incidence of side effects. The 359-patient Mayo Clinic-led collaborative study also showed that destroying as much of the fibroid as possible leads to the most durable symptom relief with 85% of the participants experiencing symptom improvement after one year.
The ExAblate system received the CE Mark for uterine fibroids in October 2002 and US Food and Drug Administration (FDA) approval in 2004. Over 5,500 women around the world have chosen to undergo the non-invasive ExAblate treatment for their symptomatic uterine fibroids over invasive surgery.
For more information, visit www.insightec.com