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02-21-2015, 09:54 PM
Pelvalon’s Eclipse Vaginal Insert for Fecal Incontinence FDA Approved
http://www.medgadget.com/wp-content/uploads/2015/02/Pelvalon.jpg
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).
Study of the Eclipse in journal Obstetrics & Gynecology: A Vaginal Bowel-Control System for the Treatment of Fecal Incontinence. (http://journals.lww.com/greenjournal/pages/articleviewer.aspx?year=9000&issue=00000&article=99193&type=abstract)
Pelvalon homepage… (http://www.pelvalon.com/)
FDA:*FDA permits marketing of fecal incontinence device for women (http://www.fda.gov/NewsEvents/Newsroom/PressAn**uncements/ucm434130.htm)
Pelvalon press release: FDA Approves Pelvalon’s Marketing Application for the Eclipse™ System, the First Vaginal Insert for Loss of Bowel Control (http://www.prnewswire.com/news-releases/fda-approves-pelvalons-eclipse-system-the-first-vaginal-insert-for-bowel-control-300035879.html)
The post Pelvalon’s Eclipse Vaginal Insert for Fecal Incontinence FDA Approved (http://www.medgadget.com/2015/02/pelvalons-eclipse-vaginal-insert-for-fecal-incontinence-fda-approved.html) appeared first on Medgadget (http://www.medgadget.com).
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http://www.medgadget.com/wp-content/uploads/2015/02/Pelvalon.jpg
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).
Study of the Eclipse in journal Obstetrics & Gynecology: A Vaginal Bowel-Control System for the Treatment of Fecal Incontinence. (http://journals.lww.com/greenjournal/pages/articleviewer.aspx?year=9000&issue=00000&article=99193&type=abstract)
Pelvalon homepage… (http://www.pelvalon.com/)
FDA:*FDA permits marketing of fecal incontinence device for women (http://www.fda.gov/NewsEvents/Newsroom/PressAn**uncements/ucm434130.htm)
Pelvalon press release: FDA Approves Pelvalon’s Marketing Application for the Eclipse™ System, the First Vaginal Insert for Loss of Bowel Control (http://www.prnewswire.com/news-releases/fda-approves-pelvalons-eclipse-system-the-first-vaginal-insert-for-bowel-control-300035879.html)
The post Pelvalon’s Eclipse Vaginal Insert for Fecal Incontinence FDA Approved (http://www.medgadget.com/2015/02/pelvalons-eclipse-vaginal-insert-for-fecal-incontinence-fda-approved.html) appeared first on Medgadget (http://www.medgadget.com).
http://feeds.feedburner.com/~ff/Medgadget?d=yIl2AUoC8zA (http://feeds.feedburner.com/~ff/Medgadget?a=PGJPdnhgIRc:qNqFMbKvnI0:yIl2AUoC8zA) http://feeds.feedburner.com/~ff/Medgadget?d=qj6IDK7rITs (http://feeds.feedburner.com/~ff/Medgadget?a=PGJPdnhgIRc:qNqFMbKvnI0:qj6IDK7rITs) http://feeds.feedburner.com/~ff/Medgadget?i=PGJPdnhgIRc:qNqFMbKvnI0:gIN9vFwOqvQ (http://feeds.feedburner.com/~ff/Medgadget?a=PGJPdnhgIRc:qNqFMbKvnI0:gIN9vFwOqvQ)
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