FDA Approves Label Change for Non-Invasive Fibroid Treatment

Label Allows Doctors to Use ExAblate(R) to Treat up to 100% of Uterine Fibroid Volume

Label Change Based on Data Showing Greater Long-Term Symptom Reduction Following More Complete Fibroid Treatment

TIRAT CARMEL, Israel, April 7 (HSMN NewsFeed) -- InSightec Ltd. announced today that the U.S. Food and Drug Administration (FDA) approved a label change for the company's ExAblate® 2000 MR-guided Focused Ultrasound (MRgFUS) system for the treatment of women with non-hysteroscopically resectable uterine fibroids. Under the new labeling, the agency allows physicians to treat up to 100% of the fibroid compared to its previous restriction to only treat up to half the fibroid tissue.

"In allowing doctors to destroy the entire fibroid, we believe the FDA has demonstrated further confidence in the safety and efficacy of the non-invasive ExAblate system," said Haywood L. Brown, MD, Chair of Obstetrics and Gynecology/Maternal-Fetal Medicine at Duke Medicine in Durham, North Carolina.

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