- InSightec's ExAblate System Uses Magnetic Resonance-guided Focused Ultrasound to Perform Uterine Procedures Without Incisions
InSightec Ltd. announced today that Japan's Ministry of Health, Labor and Welfare (MHLW) has approved the company's ExAblate(R) MR-guided Focused Ultrasound (MRgFUS) system for the treatment of women with uterine fibroids.
"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," said Dr. Kobi Vortman, President and Chief Executive Officer of InSightec. "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 hospitalizations and recovery times associated with more invasive procedures such as hysterectomy, myomectomy or UAE."
ExAblate is currently the only noninvasive treatment for uterine fibroids approved for use in Japan. Approximately 25% Japanese women will develop symptomatic uterine fibroids, primarily during childbearing years. These benign tumors can significantly impair functionality and degrade quality of life resulting in significant work absences.
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.