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Elbit Imaging Ltd. Message Board

  • rusty7860 rusty7860 Jun 3, 2004 6:13 PM Flag

    Anyone know how the FDA went today ???


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    • GAITHERSBURG, Md., June 3 (Reuters) - A U.S. advisory panel on Thursday urged regulators to approve a new treatment using ultrasound to break up fibrous clumps in the uterus, an alternative to removal of the uterus in a hysterectomy.

      The ExAblate 2000 treatment is a product of InSightec, a unit of Tel-Aviv, Israel-based Elbit Medical Imaging (Tel Aviv:EMIT.TA - News; NasdaqNM:EMITF - News).

      The final decision on approval will be made by the Food and Drug Administration. The agency usually follows the advice of its advisory panels.

      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.

      Up to 25 percent will eventually require a hysterectomy.

      The advisory panel voted 8-5 for approval. Panelists who voted against approval said the device was safe, but that they weren't convinced of its efficacy.

      Others applauded the arrival of a new treatment option. "I commend the company for giving women another choice," said Kleia Luckner, the panel's consumer representative, and a staffer at Toledo Hospital's Women's Ambulatory Health center.

      The ExAblate procedure, already approved in Europe and Israel, uses magnetic resonance imaging (MRI) to pinpoint the noncancerous tumors. Heat from ultrasound waves is then used to kill the fibroid tissue, which is flushed from the body naturally.

      Fibroids can cause miscarriages and other pregnancy problems. They are the main cause of all hysterectomies, according to the National Uterine Fibroids Foundation.

      Other treatments include pain medication and hormonal therapy.

      In a trial, 71 percent of patients treated with ExAblate had a significant improvement in pain after six months.

      Though the company only targeted smaller fibroids to minimize the heat beam going awry, five of the 109 patients had first or second degree burns.

      Five patients had leg pain and numbness due to nerve injury that lasted two days to five months, with one taking almost a year to regain feeling.

      In a written statement to the committee, National Uterine Fibroids Foundation Executive Director Carla Dionne urged against approval until there is further study.

      "It would be the recommendation of the National Uterine Fibroids Foundation that this device continue to be followed pre-market for an additional year," wrote Dionne, saying there were too many unanswered questions.

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