A Medical Device Daily
InSightec (Tirat Carmel, Israel) said that the FDA has 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.
The FDA label change was based on a growing body of evidence supporting the system's safety and efficacy, including the results of a study published in the August 2007 edition of Obstetrics and Gynecology demonstrating that patients experience longer and improved symptom reduction as a greater volume of the fibroid is destroyed.
"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 Brown, MD, chair of obstetrics and gynecology/maternal-fetal medicine at Duke Medicine (Durham, North Carolina).
ExAblate uses MR-guided focused ultrasound technology that combines MRI – to visualize the body anatomy, plan the treatment and monitor treatment outcome in real time – and high intensity focused ultrasound to thermally ablate tumors inside the body non-invasively.