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Newer MRgFUS Protocols More Effectively Treat Uterine Fibroid Symptoms

Physician affiliated with SightLine Dallas presents study findings.

DALLAS, May 14, 2007—Researchers studying MR-guided focused ultrasound surgery (MRgFUS), a new noninvasive technique for treating uterine fibroids, have determined that expanded treatment protocols bring greater symptom improvements.

Phyllis J. Gee, M.D., a board-certified OB-GYN and the first gynecologist in the United States to perform MRgFUS procedures, reported research findings in a poster presentation May 8 at the 55th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Diego. Dr. Gee is affiliated with SightLine’s Dallas clinic and is medical director of the North Texas Uterine Fibroid Institute.

In her presentation “Enhanced MR-guided Focused Ultrasound Surgery (MRgFUS) Guidelines Demonstrate Improved Efficacy and Durability for the Treatment of Uterine Myoma,” Dr. Gee reviewed results from three clinical studies:

1. The pivotal study that demonstrated MRgFUS’ safety before its FDA approval
2. A continued-access study in which some patients received treatment under the pivotal protocol and others under an expanded protocol
3. A study of African-American women receiving treatment under commercial protocols

Designed to test MRgFUS’ safety, the pivotal study, submitted for initial FDA approval, limited each patient’s treatment to two hours and to 33 percent of her fibroid volume, Dr. Gee explained. The more recent continued-access study focused instead on measuring the procedure’s efficacy. In addition to other variations, these protocols allowed 50 percent of fibroid volume to be treated and lengthened MRgFUS duration to three hours. The latest, most aggressive study was limited to African-American women, who experience a high incidence of uterine fibroids but were underrepresented in the initial pivotal study.

“Compared to patients treated with pivotal study protocols, those receiving expanded and commercial treatment showed a greater reduction in uterine fibroid symptoms and less need for subsequent alternative treatments that are often more invasive,” Dr. Gee said. “These findings further underscore the utility of MRgFUS as a long-lasting, noninvasive option for the millions of women suffering from uterine fibroids.”

Of patients treated in the continued-access study, those who received expanded treatment experienced 15 percent greater symptom reduction on average than did those treated with the pivotal protocol, according to Dr. Gee’s report. Eighty-six percent of those treated with the expanded protocol and 90 percent of those treated with the commercial protocol experienced symptom severity score improvements of 10 points or greater within three months post MRgFUS.

Dr. Gee reviewed data from eight treatment sites including the North Texas Uterine Fibroid Institute, SightLine’s Houston Clinic, Harvard-affiliated Brigham & Women’s Hospital, Johns Hopkins Hospital and the Mayo Clinic.

During an MRgFUS procedure, the patient is placed in an MRI unit on a table outfitted with an ultrasound machine. Using the MRI to visualize the fibroids, a physician focuses ultrasound waves onto them. This heats and destroys the fibroid cells. The outpatient MRgFUS procedure takes only a few hours, and patients may return to normal activities within a day or two.

For more information about Dr. Gee’s findings, please contact Eric Herrera at 713-862-2505, ext. 23, or eric@frog-dog.com.

About SightLine Health SightLine Health’s sole specialization is MRgFUS treatment for uterine fibroids. SightLine operates a series of clinics in the United States that use ExAblate, the only FDA-approved MRgFUS equipment. SightLine employs dedicated radiologists and gynecologists with decades of knowledge in female health and MRI and ultrasound technology. For more information on the procedure and on SightLine Health, visit the company on the Web at www.sightlinehealth.com.

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