BEI Medical Systems
This article was originally published in The Gray Sheet
Executive Summary
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