SUNNYVALE, Calif.--(BUSINESS WIRE)--Pelvalon today announced that new data on the Eclipse™ System will be released at the Pelvic Floor Disorders (PFD) Week 2016, which is taking place September 28-30 at the Colorado Convention Center in Denver. PFD Week coincides with the 37th Annual Scientific Meeting of the American Urogynecologic Society (AUGS), and highlights the importance of education on pelvic floor disorders, which impact one in three women.
Pelvalon is dedicated to developing innovative solutions for women suffering from loss of bowel control, a type 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. Losing bowel control can be debilitating, causing women who suffer from it to miss work, household productivity, and social interaction.
New data will be shared on the experience of the first five women to wear the Eclipse System for longer than 12 months.
“Although there is previously published multi-center evidence of positive outcomes, this is the first example of long-term use of the therapy and it is encouraging to see continued patient satisfaction with the Eclipse System in this small sample,” said study investigator Michelle Takase-Sanchez, M.D., of Ventura County Obstetric and Gynecologic Medical Group in Ventura, Calif., who will present the results.
The five women had worn the device for an average of 18.6 months at the time of data collection. Their ages ranged from 38 to 73 years, and they had each suffered from ABL for one to five years, using absorptive pads to manage symptoms. The patients represented a variety of medical histories: four participants were post-menopausal, two had previously undergone hysterectomy, one reported irritable bowel syndrome, and three women also reported symptoms of urinary incontinence. All reported ongoing satisfaction with the Eclipse System.
“In the development of any truly novel therapy, it is essential to understand the patient experience and their enthusiasm for treatment,” said Miles Rosen, co-founder and CEO of Pelvalon. “This small group of women provided invaluable feedback about the daily experience of using the Eclipse System, and we are grateful for their participation in this ongoing study.”
Dr. Takase-Sanchez’s presentation, titled “Long-Term Safety and Satisfaction of a Novel Vaginal Bowel Control System for the Treatment of Accidental Bowel Leakage in Adult Women,” will be on Friday, September 30 at 10:20 am in Room Four Seasons 4, as part of a session on Clinic-Based Urogynecology.
Pelvalon’s Eclipse System is a dynamic vaginal device designed to offer women a non-surgical treatment for loss of bowel control by modulating the size of the rectal lumen. The device includes a portion that expands to reduce the rectal lumen to prevent stool leakage and retracts to allow normal passage of stool. The device includes an external regulator to control the state of expansion. The device does not contain drugs or hormones.
Pelvalon is exhibiting at PFD Week in booth #516.
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.