The FDA has granted de **vo*regulatory approval to Pelvalon (Sunnyvale, CA) for its Eclipse Vaginal Insert for treating Fecal incontinence. The choice of orifice may be a bit surprising, but the device works by exerting pressure on the rectum through the Vaginal wall, just where a tampon is typically positioned, effectively closing off the rectum. When a trip to the bathroom is needed, the device is deflated and then re-inflated using an external pump.
The Eclipse*is intiially*fitted and inflated by a trained clinician, following which the patient can control it herself.*There has **t been anything quite like this on the market before, and though awkward may prove to be a popular drug-free solution for women struggling with bowel control. Interestingly, urinary Incontinence was **ted as a side effect.
From the FDA:
The FDA reviewed data for the Eclipse System through the de **vo classification process, a regulatory pathway for some low-to-moderate risk medical devices that are **t substantially equivalent to a legally marketed device.
The FDA granted the de **vo request based on **n-clinical testing as well as a clinical trial of 61 women with FI treated with the device. The trial showed that after one month almost 80 percent of women in the study experienced a 50 percent decrease in the number of FI episodes while using the device, as compared to baseline.
Adverse events associated with the device included pelvic cramping and discomfort; pelvic pain; Vaginal abrasion, redness, or discharge; and urinary incontinence. All device-related adverse events were mild or moderate, and **ne required any significant intervention (i.e., ** surgeries were needed).
02-21-2015, 09:54 PM
Pelvalon’s Eclipse Vaginal Insert for Fecal Incontinence FDA Approved
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