A Medical Device Daily
InSightec (Tirat Carmel, Israel) reported that the FDA cleared the company to conduct a clinical trial to evaluate the efficacy and safety of the ExAblate 2000 system using MR-guided focused ultrasound surgery (MRgFUS) for the enhancement of fertility in women with non-hysteroscopically resectable uterine fibroids who are diagnosed with unexplained infertility.
The study will measure the safety of each procedure, including pregnancy and delivery-related complications. The main efficacy goal of the trial will be to measure which procedure leads to a higher percentage of healthy live births resulting from pregnancies three to 15 months after treatment.
InSightec says ExAblate is the first system to use its 'breakthrough' MRgFUS 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.
MR thermometry, provided by the system, allows the physician to control and adjust the treatment in real time to ensure that the targeted tumor is fully treated and surrounding tissue is spared.
"While the link between uterine fibroids and infertility isn't fully understood, many women with uterine fibroids and infertility give birth to healthy babies after having their fibroids surgically removed," said Elizabeth Stewart, MD, a reproductive endocrinologist and professor of ob/gyn at the Mayo Clinic (Rochester, Minnesota). "The non-invasive ExAblate system precisely targets fibroid tissue without causing damage to the surrounding healthy areas, suggesting that it may be a safe approach for women with fibroids who want to preserve their fertility."