The FDA’s Center for Devices & Radiological health granted de novo clearance for Pelvalon’s Eclipse system for the treatment of fecal incontinence in women.
Fecal incontinence is generally caused by damage to the muscles surrounding the anus. Because vaginal childbirth can damage anal muscles and nerves, women are twice as susceptible to the condition as men, according to the agency.
The Eclipse device consists of a balloon that’s inflated in the vagina to exert pressure on the rectal wall to prevent involuntary bowel movements. The device, which is fitted by a physician, can be deflated, inflated and removed as needed by the patient.
“Current treatment options for fecal incontinence include drugs, dietary changes, exercise, and surgery,” CDRH chief scientist Dr. William Maisel said in prepared remarks. “The Eclipse system provides an additional treatment option for women who suffer from this condition.”
“This news from the FDA marks a crucial milestone for Pelvalon and validates the hard work put in by our team as well as our physician partners and investigators. A lot of women don’t talk about losing bowel control because it is embarrassing and the existing treatment options are so limited. Now, Eclipse is a reason to start talking to your doctor," Pelvalon CEO Miles Rosen said in a statement.
"I am thrilled to see the realization of a technology born here at Stanford University," added Dr. Eric Sokol of the Stanford University School of Medicine, who performed the 1st-in-human Eclipse study. "The story of Pelvalon’s rapid growth from an idea in a lab to a commercially available product in less than 5 years is remarkable, and so important for the women whose lives will be improved by this therapy."
According to Pelvalon’s website, approximately 20 million women in the U.S. suffer from some degree of bowel incontinence.