FDA approves Eclipse System for Fecal Incontinence-Pelvalon
The FDA has granted the company's de novo request to market the Eclipse System, from Pelvalon, the first vaginal insert designed to provide bowel control, in the United States. Approval is based on non-clinical testing as well as a clinical trial of 61 women with FI treated with the device. This pivotal study, LIFE, was recently released online ahead of print by Obstetrics & Gynecology. See: Richter et al. Obstet Gynecol 2015;0:1–8. Published online ahead of print.
Results showed a significant reduction in accidental loss of stool with almost 80% of the intent-to-treat population achieving treatment success, no device-related serious adverse events, and significant improvements in reported quality of life. Women who completed the study found the insert to be comfortable, and uniformly said they would recommend it to a friend. The company plans to release the Eclipse System later in 2015.
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