HAIFA, Israel (October 16, 2007) – InSightec Ltd. announced today that the European CE-marking for the ExAblate 2000 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.
“The non-invasive nature of ExAblate whereby only the uterine fibroids are ablated and there is no damage to healthy surrounding tissue suggests that MRgFUS should be a safe approach for women who want to preserve their fertility,” said Professor Lesley Regan, MD, Head of Obstetrics and Gynaecology, Imperial College, St. Mary’s Hospital, London, UK. “Clinical evidence has been accumulating to show that women have been able to conceive and successfully deliver children after undergoing MRgFUS treatment for their uterine fibroids. To date, thirteen women delivered healthy infants at term without complications and with an average of 3.4 kg birth weight. One additional pregnancy is ongoing. Eight women delivered vaginally and five delivered by cesarean section. No treatment-related adverse events were reported. Women should discuss this option with their physicians and weigh the risks and benefits against other procedures.
“We are very pleased that the European designated Notified Body has agreed to change the CE mark and enable European women with uterine fibroids who may want to become pregnant to consider MRgFUS as a treatment option with their physicians,” said Dr. Kobi Vortman, President and Chief Executive Officer, InSightec. “We are planning to further investigate ExAblate as a fertility enhancing procedure, particularly when infertility may be attributable to uterine fibroids. “
About ExAblate 2000
The ExAblate 2000 is the first system to use the breakthrough MRgFUS technology that 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, provided uniquely by the system, 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. ExAblate has been recognized for its innovation and potential to serve mankind and has been awarded the 2004 European Union's Information Society Technologies Grand Prize, The Wall Street Journal's 2004 Technology Innovation Awards, Advanced Imaging's 2005 Solutions of the Year, and most recently, the Red Herring 100 Europe 2007 Award.
About Uterine Fibroids
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 include hysterectomy, myomectomy and uterine artery embolization that are invasive and minimally invasive, involving hospitalization and several weeks of recovery time. ExAblate is an outpatient procedure and patients return home the same day and to work within one to two days.
About InSightec
InSightec Ltd. is a privately held company owned by Elbit Medical Imaging (EMI), General Electric, MediTech Advisors, LLC and employees. It was founded in 1999 to develop the breakthrough MR guided Focused Ultrasound technology and transform it into the next generation operating room. 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. For more information, please go to:
http://www.insightec.com
Contact Information
InSightec Ltd.
http://www.insightec.com/
Tel: +972-4-813-1313
Email: info@insightec.com
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