FDA approves INSIGHTEC's next-generation Exablate fibroid treatment system

FDA approves INSIGHTEC's next-generation Exablate fibroid treatment system

Press releases may be edited for formatting or style | October 08, 2015
7 October 2015 – INSIGHTEC, the leader in MR guided Focused Ultrasound (MRgFUS) therapy announces today that the United States Food and Drug Administration (FDA) has approved its next generation Exablate system to treat symptomatic uterine fibroids and changed the labeling to allow consideration for women who desire to maintain fertility. The updated labeling 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 Exablate therapy platform is transforming medicine by presenting a non-invasive treatment alternative that combines two technologies: Focused Ultrasound, which is used to ablate the fibroid tissue, and Magnetic Resonance Imaging (MRI), which is used to guide the ultrasound waves to the specific target tissue and provide real-time feedback on treatment progress and outcome. The result of the above integration is a breakthrough, non-invasive, real-time guided and controlled therapy platform that enables outpatient procedures.

This change in labeling provides younger women suffering from symptomatic fibroids access to a new, non-invasive 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 post Exablate MRgFUS treatments.

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Dr. Kobi Vortman, CEO and Founder of INSIGHTEC said, “This is a major milestone for the company. Over the years, the FDA has changed INSIGHTEC’s labeling for its uterine fibroids treatment, as more and more clinical data became available. We view this change of labeling as a significant one, because it makes MRgFUS treatment for uterine fibroids accessible to many more women in the US, including women who desire fertility-sparing options for their symptomatic uterine fibroids. INSIGHTEC will continue to invest in developing our technology, in order to treat a wider range of clinical indications".

“This is a major breakthrough in the treatment of symptomatic uterine fibroids.” said Professor Haywood Brown, MD, Chairman of Obstetrics and Gynecology, Duke University School of Medicine. “Gynecologists can now offer patients a treatment that is not only non-invasive and uterus sparing, but with the new labeling, this treatment is also an option for women who are not family complete".

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