The Japan's Ministry of Health, Labor and Welfare (MHLW) has approved InSightec’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 FDA approval in 2004.
The company said that using ExAblate system, the physician uses the Magnetic Resonance Imaging (MRI) to visualise 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 minimise motion.
Reportedly, 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.
Furthermore, the 359-patient Mayo Clinic-led collaborative study 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. Studies conducted in Japan indicate similar results.
Kobi Vortman, president and CEO of InSightec, said: “We are very pleased that the Japanese Ministry of Health has approved the ExAblate system and that women in Japan will now have access to a noninvasive treatment option for uterine fibroids. The approval was based on a growing body of evidence showing that ExAblate is a safe, effective, and durable treatment for this widespread, life-impacting condition.
“ExAblate is an outpatient procedure and patients normally return home the same day and to work within one to two days compared to lengthy hospitalisations and recovery times associated with more invasive procedures such as hysterectomy, myomectomy or UAE.”