InSightec Ltd. announced today that the European CE-marking for the ExAblate2000 for uterine fibroids has been changed to state that women planning future pregnancies should consult with their physicians before seeking treatment with the magnetic resonance-guided focused ultrasound surgery (MRgFUS) system. The CE-Mark had previously stated that only women who had completed their families should seek treatment with the non-invasive system.
This change was made based on accumulating data from studies demonstrating that women safely gave birth after undergoing MRgFUS treatment. The ExAblate system received the CE Mark for uterine fibroids in October 2002.
Uterine fibroids are benign growths in the uterus that affect more than 30% of women of childbearing age. Symptomatic women suffer from extensive and prolonged menstrual bleeding, anemia, pain, pressure and often infertility. Existing treatment options, which range to hysterectomy, can be invasive and involve hospitalization and several weeks of recovery time.
InSightec's ExAblate is an outpatient procedure and patients return home the same day and to work within one to two days.
The ExAblate 2000 combines MRI - to visualize tissues in the body, plan the treatment and monitor in real time treatment outcome - and high intensity focused ultrasound to thermally ablate uterine fibroid tissue. MR thermal feedback allows the physician to control and adjust the treatment in real time to ensure that the planned treatment outcome is achieved and surrounding tissue is spared.
ExAblate received FDA approval for the treatment of symptomatic uterine fibroids in October 2004.
InSightec Ltd. is a privately held company owned by Elbit Medical Imaging (EMI), General Electric, MediTech Advisors, LLC and employees. Headquartered near Haifa, Israel, the company has over 150 employees and has invested more than $100 million in research, development, and clinical investigations. Its U.S. headquarters are located in Dallas, Texas.
Published by Globes [online], Israel business news - www.globes.co.il - on October 18, 2007
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