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InSightec's ExAblate fibroid therapy gets Japanese approval

This article was originally published in Clinica

Executive Summary

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved InSightec's ExAblate system for the treatment of uterine fibroids. The device combines magnetic resonance imaging (MRI) to visualise the fibroids and high-intensity focused ultrasound to thermally ablate them. Fibroids are benign tumours that can cause painful and heavy menstrual bleeding, pain during sexual intercourse, and urinary frequency and urgency. Symptomatic fibroids affect around 25% of Japanese women. Other treatments are either less effective, such as hormone therapy, or involve invasive surgery including hysterectomy. Tirat Carmel, Israel-based InSightec CE marked the system for sale in Europe in 2002, and it received US FDA approval in 2004 for uterine fibroids. It is also CE marked for pain palliation of bone metastases. GE Healthcare will distribute the product in Japan.

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