FDA. US: The U.S. Food and Drug Administration today allowed marketing of the
Eclipse System for the treatment of fecal incontinence (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 FDA’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.
The FDA, an agency within the U.S. Department of Health and Human
Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines and
other biological products for human use, and medical devices. The agency
also is responsible for the safety and security of our nation’s food
supply, cosmetics, dietary supplements, products that give off
electronic radiation, and for regulating tobacco products.