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TOPAS Fecal Incontinence Device Gets Unanimous Support For Approval At FDA Panel

All members of the agency's Gastroenterology and Urology Devices Panel were convinced by Astora Women’s Health's evidence in support of PMA approval for the TOPAS mesh implant device for fecal incontinence.

The TOPAS treatment for fecal incontinence appears headed to FDA approval after the agency’s eight-member Gastroenterology and Urology Devices Panel unanimously agreed the device was safe, effective and had a favorable risk-benefit profile. There were no negative votes or abstentions on any of the panel’s three questions.

Astora Women’s Health, LLC, a subsidiary of Endo International PLC, submitted the PMA for TOPAS. The mesh implant device...

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