Devices

Reviewers Raise TOPAS System Issues

FDA medical device reviewers say there are safety issues raised by the Astora Women’s Health TOPAS treatment for fecal incontinence to be considered by the Gastroenterology and Urology Devices Panel at its 2/25 meeting. A briefing document released in advance of the meeting says the device is a permanent implant consisting of a non-bioabsorbable mesh. It is intended to treat women with fecal incontinence who have failed more conservative therapies.

There are no legally marketed mesh devices for treating fecal incontinence, FDA says, and thus the advisory panel will be asked to discuss the clinical data provided to demonstrate a reasonable assurance of safety and effectiveness in support of a PMA approval for this “first of a kind” device.

The document says the TOPAS safety profile is based on adverse events collected from 152 subjects. A total of 115 treatment-related adverse events were reported in 72 (47.4%) subjects. The reviewers recommended that if the device is approved, the company should be required to undertake two post-approval studies on safety issues. The document says that the premarket study had limitations in terms of pain assessment, pelvic flood dysfunction, and organ prolapse. “A post-approval survey could be required to more thoroughly and frequently evaluate chronic pain, pelvic floor dysfunction, and pelvic organ prolapse,” the document says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome