From Yahoo health news, at http://dailynews.yahoo.com/h/nm/2001...ruation_1.html
FDA Oks Device to Treat Excess Menstrual Bleeding
NEW YORK (Reuters Health) - CryoGen, Inc. said Monday it has received US approval to market a system for treating excessive menstrual bleeding.
The Her Option Uterine Cryoblation Therapy System consists of a slender probe with a cooling unit at the tip that is inserted into the uterus via the cervix. The probe is used to destroy the lining of the uterus. The procedure is monitored with ultrasound.
The device is the first approved cryosurgical system for abnormal uterine bleeding, a condition known as menorrhagia. It is approved for use in women whose excessive bleeding is due to benign causes. Available treatments for the condition include the use of electricity or heat to destroy the uterine lining. Such bleeding can also be treated with hormone therapy and hysterectomy.
The US Food and Drug Administration (news - web sites) (FDA)'s Obstetrics and Gynecology Advisory Committee, which recommended the approval of the device, did so with a number of conditions.
The company must provide information to ensure that the 26.5% malfunction rate seen in clinical studies had been remedied, FDA said. The committee also recommended that CryoGen conduct a six-month follow-up analysis of user technique, physician training and patient characteristics to assess why treatment results varied among clinical trial sites.
Finally, the committee said that the device's label should indicate that Her Option is intended for the reduction of uterine bleeding and that CryoGen revise its claims regarding Her Option's benefits.
Charles Tribie, president and CEO of San Diego-based CryoGen, told Reuters Health that studies are planned to address the device reliability and trial variability issues, and that the device's labeling was already finalized and approved.