FDA approves InSightec's ExAblate 2000 device
ExAblate provides a non-invasive treatment for uterine fibroids, the most common type of non-cancerous tumor in women of childbearing age
24 Oct 04 14:31
InSightec today reported that the U.S. Food and Drug Administration (FDA) has awarded pre-market approval (PMA) to the company's ExAblate 2000 system for non-invasive surgery of symptomatic uterine fibroids.
The ExAblate is the first focused ultrasound thermal ablation system approved by the FDA. It is also the first focused ultrasound surgery system using magnetic resonance (MR) guidance approved by the FDA. ExAblate will provide an alternative treatment option for women with uterine fibroids, which are the most common type of non-cancerous tumor in women of childbearing age.
The ExAblate system makes use of GE Healthcare's magnetic resonance imaging capabilities. Elbit Medical Imaging (Nasdaq:EMITF; TASE:EMIT) and GE Capital Equity Holdings, a unit of General Electric, are significant shareholders in InSightec, a privately held company headquartered in Haifa.
During the outpatient procedure the patient lies inside an MRI scanner. The MRI scanner provides three-dimensional images of the fibroid and surrounding tissue. Highly focused ultrasound waves are directed into the body; at the focal point, the ultrasound waves raise the temperature of the tissue, leading to its destruction. The patient is awake with mild sedation for the duration of the process, as opposed to the complete sedation required by surgery.
InSightec president and CEO Dr. Jacob Vortman Ph.D. called today's approval "a historic event for InSightec. By bringing together world experts in gynecology, ultrasound and magnetic resonance imaging, we have helped to commercialize the first non-invasive surgery for uterine fibroids that has the potential to provide significant relief of disease symptoms."
According to the US National Institutes of Health (NIH), at least 25% of women suffer from uterine fibroids. As many as 77% of women may actually have the condition, but may be unaware of it because they exhibit few or no symptoms. Symptoms of uterine fibroids include heavy bleeding or painful periods, bleeding between periods, pressure on the lower abdomen, frequent urination (resulting from fibroid pressure on the bladder), pain during sex and lower back pain.
To date, treatment options for uterine fibroids included invasive and minimally invasive procedures such as hysterectomy, myomectomy or uterine artery embolization (UAE). Hormonal therapy, the only non-invasive treatment available, offers only temporary relief of symptoms, and fibroids frequently grow back once therapy is terminated.
"Many women with fibroids continue to suffer with their symptoms rather than undergo treatment out of concern for the side effects of existing therapies. ExAblate 2000 gives women an important new choice to help reduce the symptoms of uterine fibroids," said Brigham and Women's Hospital and co-principal lead investigator Dr. Elizabeth A. Stewart MD.
Vortman said that InSightec was exploring the potential application of the ExAblate system in other diseases such as breast, liver, bone and brain cancer.
The device has already received the European CE mark and ISO 9001 and is commercially available in Israel, Europe, and Asia. ExAblate was awarded the 2004 European Information Society Technologies grand prize for innovation and potential to serve mankind. Over 700 women around the world have already been treated with ExAblate 2000.
The FDA approval to market ExAblate followed a multi-national trial conducted in 109 women with symptomatic uterine fibroids at seven medical centers around the world. After six months, 70.6% of the women reported a significant improvement in fibroid-related symptoms. The study compared the results of ExAblate treatment with total abdominal hysterectomy. Patients treated with ExAblate missed 1.2 working days, on average compared to an average of 19.2 days for the hysterectomy group in the first 30 days post- surgery. They returned to normal activity in less than three days, compared to 17 days for the hysterectomy group. Adverse events, while rare, included minor skin burns and a few instances of nerve injury, all of which resolved within one year.
Currently, seven major medical centers in the US are equipped with the ExAblate 2000 System. They are: Brigham and Women's Hospital in Boston, MA; Johns Hopkins Hospital in Baltimore, MD; Mayo Clinic in Rochester, MN; University MRI in Boca Raton, FL; Tower Beverly Radiology - Radnet in Beverly Hills, CA; Virtua Health in Voorhees, NJ; and the Lahey Clinic in Burlington, MA.
Published by Globes [online] - www.globes.co.il - on Sunday, October 24, 2004
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