SUNNYVALE, Calif.–(BUSINESS WIRE)–Pelvalon today announced data from a feasibility study of the first generation of the company’s Eclipse™ System, a novel vaginal insert designed to offer a nonsurgical treatment for women suffering from loss of bowel control.
Presented today at PFD Week, an expansion of the American Urogynecologic Society (AUGS) 36th Annual Scientific Meeting in Seattle, the data demonstrated a similar success rate to that shown in the later pivotal trial of the device, called LIFE.
PFD Week highlights the importance of education on pelvic floor disorders, which impact one in three women. Loss of bowel control is a form of pelvic floor disorder. Often called accidental bowel leakage (ABL) or fecal incontinence (FI), the condition can be caused by pregnancy, childbirth, nerve or muscle damage in the pelvic region, and irritable bowel syndrome (IBS) or other gastrointestinal conditions. More than 20 million U.S. women suffer from ABL.
“The results of the feasibility study for this treatment are important because they show the consistency of data that has supported the Eclipse System,” said study investigator Michelle Takase-Sanchez, M.D., of Ventura County Obstetric and Gynecologic Medical Group in Ventura, Calif., who presented the results.
This feasibility study was an IRB-approved, prospective, multi-center, open-label clinical study that enrolled 86 women over the age of 18, both with and without ABL. Initially, the subjects were assessed during an in-office fitting of the system only, in order to provide an understanding of how to fit the device in different anatomies. A subset of 15 patients with ABL wore the system for up to three months, and took quality of life questionnaires and/or kept bowel diaries to establish a baseline of ABL instances and determine satisfaction and comfort related to the system.
Baseline and one-month assessments by diary were available for nine of the 15 patients. Eight of nine (89 percent) experienced a more than 50 percent reduction in episodes and a little over half of the patients (five of nine, or 56 percent) experienced a 100 percent reduction. Assessments of satisfaction regarding the insert were available from 14. Thirteen (93 percent) reported they would continue using the insert, and all 14 reported they would recommend the device to a friend. Of the seven who completed the assessment questionnaire, the majority (six out of seven) reported that they couldn’t feel it, and the others could feel the insert, but it was “not uncomfortable.”
“We believe in a robust and methodical approach to clinical research,” said Miles Rosen, co-founder and CEO of Pelvalon. “This feasibility study set the stage for the subsequent LIFE pivotal trial used to support our FDA submission. The consistency of results across multiple studies with different cohorts and investigators is encouraging.”
Pelvalon’s Eclipse System 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. The system was cleared by the FDA in February 2015 for the treatment of fecal incontinence in adult women.
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.