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
Nicole Osmer, 650-454-0505