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ORLANDO, FLA. -- Women with menorrhagia may soon have a new outpatient treatment option.
The Hydro ThermAblator, an investigational device that circulates hot saline through the uterus to ablate the endometrium, is under review by the Food and Drug Administration for premarket approval.
In clinical trials, use of the device, developed by BEI Medical Systems, resulted in an average 84.8% reduction in bleeding in 167 women studied. Bleeding was eliminated in more than 40% of the women at a 12-month follow-up. Results were comparable with roller-ball ablation in terms of efficacy and amenorrhea rate, with a failure rate of about 5%, Dr. Stephen L. Corson, the company's medical director, reported at the annual meeting of the American Association of Gynecologic Laparoscopists.
The HydroThermAblator involves a special sheath, including a hysteroscopic telescope, which ...
Source: HighBeam Research, New Endometrial Ablation Device on the Horizon.