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FDA permits marketing of fecal incontinence device for women

The U.S. Food and Drug Administration has allowed marketing of the Eclipse System for the treatment of (FI) in adult women.

Fecal incontinence is the inability to control bowel movements and is a common problem, especially among older adults. The most common cause of FI is damage to the muscles around the anus (anal sphincters). Vaginal childbirth can damage the anal sphincters or their nerves, which is why FI impacts women about twice as often as men.

“Current treatment options for fecal incontinence include drugs, dietary changes, exercise, and surgery,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the ’s Center for Devices and Radiological Health. “The Eclipse System provides an additional treatment option for women who suffer from this condition.”

The Eclipse System is intended to treat FI in women 18 to 75 years old who have had four or more FI episodes in a two-week period. The device includes an inflatable balloon, which is placed in the vagina. Upon inflation, the balloon exerts pressure through the vaginal wall onto the rectal area, thereby reducing the number of FI episodes. The device is initially fitted and inflated by a clinician (with the use of a pump) and after proper fitting, the patient can inflate and deflate the device at home as needed. The device should be removed periodically for cleaning.

The FDA reviewed data for the Eclipse System through the de novo classification process, a regulatory pathway for some low-to-moderate risk medical devices that are not substantially equivalent to a legally marketed device.

The FDA granted the de novo request based on non-clinical testing as well as a clinical trial of 61 women with FI treated with the device. The trial showed that after one month almost 80 percent of women in the study experienced a 50 percent decrease in the number of FI episodes while using the device, as compared to baseline.

Adverse events associated with the device included pelvic cramping and discomfort; pelvic pain; vaginal abrasion, redness, or discharge; and urinary incontinence. All device-related adverse events were mild or moderate, and none required any significant intervention (i.e., no surgeries were needed).

The Eclipse System is manufactured by Pelvalon, Inc., in Sunnyvale, California.

Source

Related Information:

FDA: Medical Devices

FDA: Evaluation of Automatic Class III Designation (De Novo) Summaries

Source: FDA