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FDA Approves Upgraded FUS Fibroid System

Thursday, October 22, 2015  
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The FDA has approved broadened treatment options available to the millions of women who suffer from uterine fibroids. First, the FDA approved a more advanced next generation ExAblate system for fibroids. In addition, the FDA removed the “family complete” requirement, confirming that women who want to maintain their fertility can use FUS to treat their fibroids.

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.

The labeling change 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.

Professor Alan H. Matsumoto, MD, Radiology Chairman at the University of Virginia and President of the Society of Interventional Radiology commented: "The new version of the Exablate system enables treating physicians greater control of and more flexibility in treating fibroids with a clearer 3D view of the on-going treatment. With this new technology, treatment time is reduced allowing for treatment of more fibroid tissue in a given time".

INSIGHTEC’s treatment platform was approved by the United States FDA for the treatment of the entire symptomatic fibroid tissue in 2009. This is the second labeling adjustment approved by the FDA since then.

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