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Dr Heilbronn Completes FDA Study

09-18-2006

As new medical products and services are introduced into the population, the Federal Drug Administration (FDA) requires extensive testing. This testing is done both in laboratory settings and under strict protocols in selected health care settings (hospitals and/or physician offices).

One such FDA study is AMS043: "A study to evaluate the effectiveness of extended treatment regimens with the HerOption cryoablation therapy system for treatment of menorrhagia."

Our Dr. Heilbronn participated in this study. With the cooperation of eight VOB patients, he performed this in-office procedure which is designed to help those patients who suffer from excessively heavy and/or prolonged menstrual periods. Under ultrasound guidance, he placed a freezing probe into the uterine cavity of these patients and performed a freezing technique that had been previously done in many different settings, but this was being done in such a way to prolong the freezing time to see if it would be more effective in eliminating heavy or prolonged periods. After the freezing technique was performed, the patients have been followed along a strict protocol to evaluate the effectiveness, many of whom are now greater than one year out from their procedure. The patients will be followed for a total of three years under the current protocol, and while preliminary results have been published, the final results will not be until all patients enrolled have completed their three years of study.

This study was conducted throughout 10 centers in the United States with a total of more than 70 patients involved. So far, all of the patients have, in general, shown good improvement with no significant adverse events. Stay tuned for further updates on the results!