According to Globes Online, the Food and Drug Administration U.S. has expanded the indication for InSightec ExAblate Ltd 2000 MRguided Focused Ultrasound (MRgFUS) system for the treatment of women with uterine fibroids hysteroscopically not resectable. The system developed by InSightec, an Israeli company, can now be used to treat up to 100% of fibroids compared to the previous indication that enabled the processing of only half of the fibroid tissue. br ldquo; By allowing doctors to destroy the fibroid all, we believe that the FDA has shown greater confidence in the safety and efficacy of noninvasive ExAblate system, rdquo;, br said the label change was based on FDA a growing body of evidence supporting the systemrsquo; s safety and efficacy, including the results of a study published in the August 2007 edition of Obstetrics and Gynecology shows that patients experience more and better symptom reduction as a higher fibroid volume is destroyed. br ldquo; Wersquo; re very pleased that the FDA approved this important label change and we believe this highlights the security of our system, the only noninvasive treatment for uterine fibroids available today, rdquo said Dr. Kobi Vortman, President and Chief Executive Officer of InSightec. ldquo; We remain committed to the continued expansion of our treatment indications and applications through research. An ongoing research study to evaluate the potential treatment of fibroids with the ExAblate system to increase fertility when other potential causes of womenrsquo; s infertility have been ruled out. The study will compare the birth rates of women undergoing ExAblate treatment for those with a surgical myomectomy.rdquo; br ldquo; evidence supporting the removal of fibroids distort the uterine cavity to increase pregnancy rates and reduce miscarriage rates, rdquo, Dr. Brown said. This study tests the premise that women have not benefited from the minimally invasive treatment. br improves fertility study is conducted at the Mayo Clinic in Rochester, Minnesota, Duke University in Durham, North Carolina Health and Wellness Willowbend in Plano, Texas, and Focused Ultrasound Northwest in Renton, Washington. For more information about the study please visit www.clinicaltrials.gov/ br To date, InSightec reported 54 pregnancies, 22 deliveries with 11 ongoing pregnancies in women who previously underwent the procedure ExAblate. br br
