Gynecologists Likely To Have New Options For Treating Menorrhagia In 2001
This article was originally published in The Gray Sheet
Executive Summary
BEI Medical Systems' Hydro ThermAblator (HTA) system for endometrial ablation will provide a new option for gynecologists in the treatment of menorrhagia when it becomes available, likely in early 2001.
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BEI Medical Systems
Preliminary Phase III results for firm's Hydro ThermAblator (HTA) system in treating excessive uterine bleeding indicate that over 80% of 166 women experienced reduction in uterine bleeding, firm reports Sept. 6. BEI plans to submit results as the final part of its PMA approval application in mid-September. The firm already has filed three PMA modules with the agency (1"The Gray Sheet" Aug. 21, 2000, p. 13). The company also notes that the HTA completely eradicated menstrual bleeding in approximately 40% of treated patients
BEI Medical Systems
Preliminary Phase III results for firm's Hydro ThermAblator (HTA) system in treating excessive uterine bleeding indicate that over 80% of 166 women experienced reduction in uterine bleeding, firm reports Sept. 6. BEI plans to submit results as the final part of its PMA approval application in mid-September. The firm already has filed three PMA modules with the agency (1"The Gray Sheet" Aug. 21, 2000, p. 13). The company also notes that the HTA completely eradicated menstrual bleeding in approximately 40% of treated patients
BEI Medical Plans Year 2000 PMA Filing For Endometrial HydroThermAblator
BEI Medical Systems is on target to complete Phase III studies of its Hydro ThermAblator system for thermal endometrial ablation in the first quarter.