Adiana Approves Alternative Procedure for Tubal Ligation
The FDA Obstetrics and Gynecology Devices Panel recently recommended approval of an alternative approach to tubal ligation that employs a device called Adiana. The device is manufactured by Massachusetts-based Hologic, Incorporated. Information about the approval was described in a press release issued by Hologic.
Adiana uses low level bipolar radiofrequency signals to create a small lesion about 1 cm within the fallopian tube using hysteroscopy. This minimally invasive approach does not require any incisions. A catheter is then used to implant a soft polymer called a matrix, smaller than a grain of rice, into the tube. The same procedure is completed for both fallopian tubes.
Over time, healthy tissue grows both on the matrix as well as around it. This creates a permanent blockage within the tube. Three months after the procedure is completed, a hysterosalpingogram is completed to ensure blockage. This validates if women can rely solely on the Adiana to prevent conception.
The procedure can be completed in the outpatient setting, patients receive a local anaesthetic, and is finished in about 15 minutes. Women can generally return to normal activities the day after the procedure is completed. Based on data submitted to the FDA from 600 different female participants, the device has a sterilization rate of 98.9 percent during one year of follow up.
Conditions that were issued along with the approval recommendation from the Panel include ongoing, long-term follow-up of those patients who have already undergone the procedure, additional post-marketing studies in patients who receive the device following this approval, and labeling recommendations.
The alternative procedure most commonly employed is bilateral tubal ligation. Almost 700,000 women undergo the procedure each year in the U.S. It is most often completed in the operating room under general anaesthesia and, as such, carries a higher level of risk than Adiana.
December 20, 2007 Related topics: New Technology & Innovation, Obstetrics, Gynecology & Neonatology