MRgFUS Offers Women the Only Non-Invasive Treatment for Symptomatic
HAIFA, Israel, March 12 /CNW/ - InSightec Ltd. announced today that
Canada's healthcare regulatory body, Health Canada, has granted regulatory
approval to the company's ExAblate(R) 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 Chief
Executive Officer of 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 was approved by the U.S. Food and Drug Administration (FDA) in
October 2004 and to date over 2,500 women have been treated worldwide for
symptomatic uterine fibroids.
"Non-invasive therapy with ExAblate has the potential to dramatically
change the way surgery is conducted" said David Gianfelice, MD, lead
researcher. "We are delighted that Canadian women suffering from uterine
fibroids will now have access to this technology."
Doctors from 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.
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 targeted tumor is fully
treated 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, and
Advanced Imaging's 2005 Solutions of the Year.
Uterine fibroids are benign growths in the uterus that up to 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 and are 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.
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 135 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:
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