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The Eclipse System is indicated for treatment of fecal incontinence in adult women. It is intended for prescription use.

The Eclipse System includes two main components, an Insert and a Pump. The Insert is used intra-vaginally, is insertable/removable by the patient, and includes a balloon that when inflated, exerts a force posteriorly (trans-vaginally) against the wall in the rectum resulting in a decrease in the lumen of the rectum. The compression of the rectal space results in decreased frequency of fecal incontinence events. The Eclipse System also contains two tools for the fitting process: a Sizing Kit, consisting of Sizers in each available Insert Base size, and a Trial Insert. Each component is described below. - -Sizing Kit / Sizers: Reusable (multi-patient) Insert Bases (Sizers), intended to aid in selecting appropriate Trial Insert Sizes. Sizers are only used in a clinical setting (<60 minutes) and are not intended to be taken home. - -Trial Insert (Insert): Single-patient-use vaginal insert intended for short term use (approximately 1 week, but no more than 2 weeks) during the fitting and evaluation process. Multiple Trial Inserts may be attempted to achieve a correct fit. The Trial Inserts are identifiable by their white color. - Eclipse Insert (Insert): Single-patient-use vaginal insert intended for longer-term use (up to 1 year). The Eclipse Inserts are identifiable by their indigo color. - -Pump, including Regulator: The pump is used by the patient for inflating and deflating the balloon with a goal of improving control over bowel movements. The Pump includes a replaceable Regulator which regulates the maximum pressure of the Insert's Balloon. Regulators are available for different pressure levels, and can be replaced to adjust the maximum pressure of the Insert's Balloon.

The Eclipse System is indicated for the treatment of fecal incontinence in adult women. It is intended for prescription use.

The Eclipse System is a device intended to treat women with fecal incontinence (FI), also referred to as "accidental bowel leakage", or "bowel control disorder". The Eclipse System contains the Eclipse Insert and the Pump, including Regulator. The Eclipse Insert is used intra-vaginally, is insertable/removable by the patient, and includes a balloon that when inflated, exerts a force posteriorly (trans-vaginally) against the wall in the rectum resulting in a decrease in the lumen of the rectum (Figure 1). The compression of the rectal space results in decreased frequency of fecal incontinence events. The Eclipse Insert consists primarily of a silicone and stainless steel base with an inflatable silicone balloon. The pump is used by the patient for inflating and deflating the balloon with a goal of improving control over bowel movements.