Devices

Panel to Review Endovascular Graft Device Endoleaks

CDRH says it will hold a two-day meeting of its Medical Devices Advisory Committee’s Circulatory System Devices Panel to review information about the benefit-risk profile of Endologix’s AFX endovascular graft system pertaining to Type III endoleak risks. The agency intends to request panel feedback on the data collected on AFX devices and whether further regulatory actions are necessary.

Panel members are also scheduled to discuss and make recommendations on the continued safety and effectiveness of endovascular stent grafts and how to strengthen real-world data collection on long-term device performance, both for currently marketed devices and for future technologies. “The FDA intends to request panel input on the clinical outcomes that are most relevant to capture in the real world, along with their frequency and duration,” an agency notice says. “Additionally, the FDA intends to seek input on data collection platforms, and how to incentivize and optimize real world data collection.”

Enologix’s device has been on FDA’s safety radar for a few years. Late last year, the agency updated a 2019 safety communication on the device used in treating abdominal aortic aneurysms and the risks associated with Type III endoleaks with the devices (see story).

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