FDA Approves Label Change for Non-Invasive Fibroid Treatment
- Created: April 6, 2009
- by: admin
TIRAT CARMEL, Israel, April 7 /PRNewswire/ — InSightec Ltd. announced today that the U.S. Food and Drug Administration (FDA) approved a label change for the company’s ExAblate(R) 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.
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.
“We’re extremely pleased that the FDA approved this important label change and believe this underscores the safety of our system, the only non-invasive treatment for uterine fibroids available today,” said Dr. Kobi Vortman, President and Chief Executive Officer of InSightec. “We remain committed to continuously expanding our treatment indications and applications through research. An ongoing research study is evaluating the potential of treating fibroids with the ExAblate system to enhance fertility when other potential causes of women’s infertility have been ruled out. The study will compare birth rates of women who underwent ExAblate treatment to those who had a surgical myomectomy.”