SUNNYVALE, Calif.--(BUSINESS WIRE)--Pelvalon, manufacturer of the recently FDA-cleared Eclipse™ System, today announced the presentation of a new clinical analysis of the LIFE study. The study, previously published in Obstetrics & Gynecology, was the pivotal trial of this first-of-its-kind treatment for women experiencing loss of bowel control that was the basis for the recent FDA clearance of the device. This new analysis examined the symptoms that often occur when bowel control is lost: urgent bowel movements, loose stool, frequent bowel movements, and incomplete evacuation.
Madhulika G. Varma, M.D., professor and chief of Colorectal Surgery in the department of Surgery at University of California-San Francisco Medical Center, presented the results last week at the 2015 American Society of Colon and Rectal Surgeons (ASCRS) Annual Scientific Meeting in Boston, Mass.
The analysis focused on symptoms that occur with loss of bowel control. Women with fecal incontinence who were fitted with an Eclipse insert in the study recorded information about every bowel movement, continent and accidents, in a diary. The following results were reported among the 61 women studied, based on one month of insert wear:
- Stool frequency: 67% of patients who experienced an average of two or more bowel movements per day reported a statistically significant reduction in frequency of bowel movements
- Bowel urgency: a 34-point reduction in patients reporting urgency after one month (73% reported urgency at baseline, compared to 39% reporting urgency at one month, p=0.0005)
- Stool consistency: 32-point reduction in number of patients reporting liquid stool (64% of patients at baseline, and 31% at one month, p=0.001)
- Complete evacuation, including a 19-point reduction in number of patients reporting incomplete evacuation (55% of patients at baseline, and 36% at one month, p=0.057)
“These symptoms, which are common for women suffering from loss of bowel control, are devastating for patients,” said Dr. Varma. “With the recent FDA clearance of the Eclipse System, I am thrilled that we will soon have a new option for women that is clinically proven to immediately and effectively reduce accidents and improve quality of life.”
As previously reported, the LIFE study demonstrated the safety and effectiveness of Eclipse in 61 women, with high efficacy (79%), an outstanding safety profile with no serious device-related adverse events, and significant improvements in quality of life, with 98% of patients saying they would recommend the system to a friend. Not all women can be fit with the insert, and the majority of adverse events (all mild or moderate, such as pelvic discomfort) were experienced during the fitting period. 96% of women who finished the treatment period said they found it comfortable. Results of the study were submitted to the U.S. Food and Drug Administration (FDA) as part of the company’s application for clearance to market the system in the United States, granted in February this year.
“These new findings further support the use of the Eclipse System in the treatment of fecal incontinence,” said Miles Rosen, CEO of Pelvalon. “We were gratified by the excitement about the treatment at the ASCRS meeting this year, and look forward to bringing Eclipse to patients and physicians in a commercial setting this fall.”
More than 20 million U.S. women suffer from an inability to control bowel movements, a condition that can be caused by pregnancy, childbirth, nerve or muscle damage in the pelvic region, and irritable bowel syndrome (IBS). The Eclipse System is the first vaginal insert designed to provide bowel control. The insert is placed in the same location as a tampon or a diaphragm, and can be removed at any time. A hand-held pump is used to inflate and deflate a balloon on the insert. The balloon is designed to occlude the rectum to protect against unwanted stool passage. The insert is does not contain drugs or hormones, and is intended to offer women a non-surgical treatment option.
Headquartered in Sunnyvale, California, privately held Pelvalon aims to improve the lives of women who suffer from bowel control problems. Founded in 2010, Pelvalon’s groundbreaking technology originated from Stanford University’s Biodesign program, a collaboration between the schools of medicine and engineering. Pelvalon’s investors include Norwich Ventures, a specialized venture capital firm focused on medtech.