Astora lands FDA panel date for Topas incontinence device

The FDA today scheduled a panel date to discuss the premarket approval submission from Astora Women’s Health for its Topas incontinence device.

The company and federal watchdog are slated to meet in late February to consider the company’s sling mesh device.

The Topas is designed to be implanted around the puborectalis muscle for treating women with fecal incontinence who’ve failed more conservative therapies.

The meeting will be split into multiple sessions, in which the company and members of the agency will discuss reclassification topics related to women’s health devices.

Topics range from reclassification of urogynecologic surgical mesh instrumentations from class I devices to class II, to shifting FDA classification product codes, according to an FDA release posted today.

The meeting comes shortly after the FDA, prompted by a significant increase in complaints about a type of surgical mesh used to treat pelvic organ prolapse in women, put the mesh products under its most stringent level of review.

The federal safety watchdog said it re-classified the mesh from Class II to Class III and will require makers to go through its pre-market approval process for transvaginal POP procedures. The moves do not apply to mesh used in other indications, including stress urinary incontinence and abdominal POP repair, the FDA said.

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