FDA Approves InSightec's Next-Generation ExAblate Fibroid Treatment System

October 7, 2015—InSightec, an Israel-based manufacturer of magnetic resonance-guided focused ultrasound (MRgFUS) therapy products, announced that the US Food and Drug Administration (FDA) has approved the company’s next-generation Exablate system to treat symptomatic uterine fibroids.

The FDA also approved a change of the labeling, to allow for the consideration of women who desire to maintain fertility, which specifies that ablation of uterine fibroid tissue can now be considered for women with symptomatic uterine fibroids who desire to retain fertility and spare their uterus.

InSightec’s noninvasive Exablate therapy platform combines focused ultrasound to ablate the fibroid tissue and magnetic resonance imaging to guide the ultrasound waves to the specific target tissue and provide real-time feedback on treatment progress and outcome.

The change in labeling provides younger women with symptomatic fibroids access to a new, noninvasive treatment option that is safe, effective, and keeps their uterus intact without compromising their existing ability to get pregnant. The approval is based on accumulated, documented clinical data on 118 patients’ pregnancies after treatment with Exablate MRgFUS.

In the company’s announcement, Prof. Haywood Brown, MD, commented, “This is a major breakthrough in the treatment of symptomatic uterine fibroids. Gynecologists can now offer patients a treatment that is not only noninvasive and uterus sparing, but with the new labeling, this treatment is also an option for women who are not family complete.” Prof. Brown is Chairman of Obstetrics and Gynecology at Duke University School of Medicine in Durham, North Carolina.

Eric Dolen, MD, of Ohio Health in Columbus, Ohio, added, “MRgFUS is a valid treatment option for patients with symptomatic uterine fibroids. This change in labeling acknowledges this treatment option to be suitable not only for women who are family complete, but also for women who still plan on conceiving.”

Also, in InSightec’s press release, Prof. Alan H. Matsumoto, MD, who is Radiology Chairman at the University of Virginia in Charlottesville, Virginia, and President of the Society of Interventional Radiology, discussed the benefits of the new system. Dr. Matsumoto stated, “The new version of the Exablate system enables treating physicians greater control of, and more flexibility, in treating fibroids with a clearer three-dimensional view of the ongoing treatment. With this new technology, treatment time is reduced, allowing for treatment of more fibroid tissue in a given time.”