Spotlight On... Endo 'reviewing options' for its incontinence device due to closure of its women's health unit; Medtronic starts TAVI outcomes trial; Ethicon touts positive data for fibrin sealant patch; and more...

Endo ($ENDP) is pulling out of the vaginal mesh business due to billions of dollars of litigation costs associated with the (often hazardous) devices for pelvic organ prolapse and urinary incontinence. But the company has said that its investigational mesh-based Topas device to treat fecal incontinence among women "does not require transvaginal incision, or any incision or modifications to the pelvic floor muscle, and thus has a different safety profile than transvaginal mesh device." As a result, it could represent a viable financial opportunity. In light of the pending closure of Astora Women's Health, Endo is reviewing its best options for the "valuable" device, and has notified FDA accordingly, a company spokeswoman told FierceMedicalDevices. The agency's review process is continuing. In spite of the inevitable comparisons to vaginal mesh, the FDA's Gastroenterology-Urology Devices Panel unanimously voted that the device is safe and effective, making approval likely. It seems like a company that it is committed to devices will have the opportunity to commercialize the Topas, assuming it is willing to pay Endo an appropriate sum for the rights to the development program and technology. More about the Topas | Prior coverage of the closure of Astora

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