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Tyco trumpets Vesta system

advisers that its Vesta system to treat excessive menstrual bleeding offers a new alternative to hysterectomies.

The surgical product maker, recently acquired by Tyco, already sells the Vesta system outside the US and is hoping to win US Food and Drug Administration approval. Company officials presented studies of the product yesterday to an expert FDA advisory panel called to give a recommendation to the agency.

Company officials told the panel that doctors found the Vesta system easier to use than a procedure known as the "rollerball'' technique, until recently one of the few treatment options for the condition besides a hysterectomy, a procedure in which the uterus is removed.

"Vesta was easier to learn and easier to use,'' according to doctors who participated in the study, said Stephen Corson, a professor and researcher at Thomas Jefferson University who presented data on behalf of the company. "It may provide increased access to gynecologists and their qualified patients seeking an alternative to hysterectomy.'' The FDA typically follows the advice of its expert panels. Tyco has been expanding its product line through acquisitions in response to consolidations of hospitals and health insurers.

In May, it agreed to buy US Surgical Corp., which had previously acquired Valleylab, for about $3.89 billion.

The Vesta system is designed to treat women who have such excessive menstrual bleeding that their quality of life, and even health, is damaged. Heavy or lengthy menstrual bleeding, called menorrhagia, can be caused by benign tumours known as fibroids in the uterus. About 19 percent of menstruating women suffer from the condition worldwide, which is the primary source of anaemia in women. Only a small percentage of those women, however, have severe enough menorrhagia that they will seek treatment, analysts said. If approved, the device would compete with a similar device made by Johnson & Johnson's Gynecare unit, approved by the FDA last year.

The new systems are key for women trying to avoid a total hysterectomy. The alternative rollerball technique -- in which doctors cut away the lining of the uterus -- is effective, yet gynecologists rarely offer the option because the technique is difficult to master. -- Bloomberg