Medical Advances
If you are interested in some of the most modern advances in today's health sciences the following is a must see - truly an awesome video.
http://www.youtube.com/watch?v=qxhi4Q8EDTU
WASHINGTON (Reuters) - A new treatment using ultrasound to break up fibrous clumps in the uterus could soon become the first U.S.-approved alternative to hysterectomies and other surgical treatments.
InSightec, a subsidiary of Tel-Aviv, Israel-based Elbit Medical Imaging, is seeking U.S. Food and Drug Administration's approval for the new treatment, called ExAblate 2000.
On Thursday, an advisory panel to the FDA is due to discuss whether to recommend approval of the procedure. The agency usually follows its panels' advice.
The procedure, already approved in Europe and Israel, uses magnetic resonance imaging (MRI) to pinpoint the non-cancerous tumors. Heat from conventional ultrasound waves is then used to kill the fibroid tissue, which is flushed from the body naturally.
In a clinical trial of ExAblate 2000, patient symptoms improved by about 71 percent over six months, exceeding the main goal of the trial, which was a success rate at six months of at least 50 percent, according to documents posted on the FDA's Web site, www.fda.gov, on Wednesday.
The documents, compiled by FDA staff, noted a number of side effects during the trial including nerve injury, leg pain, bowel symptoms, bladder symptoms and skin injury.
About 80 percent of women suffer from uterine fibroids at some point in life, according to the National Institutes of Health. Symptoms include pain, bleeding and uterine swelling, but some women have no symptoms.
Fibroids can also cause miscarriages and other pregnancy problems.
Not all fibroids require treatment, but about one quarter of women who suffer from them require surgery, InSightec said. According to the National Uterine Fibroids Foundation, fibroids are the main cause of all hysterectomies, which involve the surgical removal of the uterus.
Other treatments include pain medication and hormonal therapy.
"So many women don't want to go through any kind of surgical
intervention. They live with their symptoms, and their fibroids continue to
grow," said Dr. Elizabeth A. Stewart, an associate professor at Harvard
Medical School who led one of the studies for the technique.
National Uterine Fibroids Foundation Executive Director Carla Dionne said women with fibroids are desperate for non-surgical options.
But the ExAblate 2000 -- which takes a couple of hours and can require follow-up sessions -- may be a time-consuming and costly alternative, especially for women with many fibroids, she said.
"There's temporary relief for now, and six months later they have more fibroids that need to be zapped," Dionne said.
Officials for Israel-based InSightec declined to comment ahead of the FDA meeting.
The company is also studying ExAblate 2000 as a possible treatment for
breast cancer and other breast tumors.
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