InSightec's ExAblate 2000 system gets Health Canada OK

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Haifa, Israel-based InSightec has gotten regulatory approval from Health Canada for its ExAblate 2000 magnetic resonance-guided focused ultrasound (MRgFUS) incisionless surgery system for the treatment of symptomatic uterine fibroids.

"We're very pleased that the Canadian government has approved ExAblate, the only non-invasive treatment option for women suffering from the painful, symptoms of uterine fibroids," said Jacob Vortman, PhD, president and CEO, InSightec. "This approval expands access to this revolutionary incisionless surgery technology and offers Canadian women an alternative to hysterectomy and other invasive surgeries to treat this condition. Instead of lengthy hospitalizations and weeks of recovery time, the outpatient ExAblate procedure allows women to return home after treatment and get back to normal activities with their families and jobs within two days."

ExAblate uses MR guided focused ultrasound which combines magnetic resonance imaging (MRI) to visualize tissue in the body, plan and monitor the treatment and outcome in real time and high-intensity focused ultrasound energy to thermally ablate (destroy) tissue non-invasively.

ExAblate which received FDA clearance back in October 2004, has thus far treated 2,500 women worldwide for symptomatic uterine fibroids.

According to InSightec, physicians at the Mount Sinai Hospital and University Health Network (UHN) Joint Department of Medical Imaging in Toronto, Ontario are conducting clinical studies on uterine fibroids, pain palliation of patients suffering from advanced bone metastases and breast tumors using the ExAblate 2000.