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This application is to obtain approval for clinical use of the Fenix, a Humanitarian Use Device. The Fenix device was just approved by the FDA as a Humanitarian Exempt Device for fecal incontinence. It has only been utilized in small numbers in Europe. There was a previous device produced by American Medical Systems, who sold their artificial bowel sphincter to Boston Scientific. Boston Scientific has elected to not continue the manufacturing of the artificial bowel sphincter. Investigators hope the Fenix will provide patients an alternative to colostomy.
The Fenix is surgically placed either by a perineal approach or by laparoscopy. This surgery could be an outpatient procedure or at most an overnight stay in the hospital. The design of the device allows it to be effective immediately. The device is similar to the Lynx device used for esophageal reflux. It is a circular set of magnets which surrounds the rectum. The size of the device is determined at the time of surgery so that there is coaptation of the rectum when closed. When the patient strains at stool, this pressure separates the magnets and allows passage of stool. The magnets are held together my malleable metal ring. Once straining at stool stops, the magnets are able to re-connect or close the rectum.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Artificial rectal sphincter for fecal incontinence
Mayo Clinic in Florida
Published on BioPortfolio: 2016-03-31T09:53:24-0400
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