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In Brief: Gynecare

This article was originally published in The Gray Sheet

Executive Summary

Gynecare: Submits premarket approval application to FDA for its ThermaChoice uterine balloon therapy system following completion of six-month follow-up from a 255-patient clinical trial of the device. The system is intended to treat menorrhagia, or excessive menstrual bleeding, a condition Gynecare says affects about 19% of menstruating women worldwide. Gynecare's clinical trial, conducted at 12 U.S. and two Canadian sites, compared use of ThermaChoice to electrosurgical ablation with a rollerball in women with blood flows of more than 80 cc each month. Based on a diary scoring system used in the study to assess blood loss, Gynecare says the two methods led to comparable reductions in blood loss. About 69.4% of ThermaChoice patients (n=131) were completed in less than 30 minutes versus 28.6% of rollerball patients (n=124)...

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