Devices

FDA Alert Update on Endovascular Grafts

FDA has updated a 2018 safety alert about Endologix’s AFX endovascular graft systems used in treating abdominal aortic aneurysms (AAA) and the risks associated with Type III endoleaks with the devices. The new safety communication comes after the agency evaluated new information from recent real-world data, published in a conference abstract, suggesting that there may also be endoleak risks occurring with two other AFX endovascular grafts — AFX with Duraply and AFX2 — which is in addition to the original alert on the AFX with Strata device.

In the new safety communication, FDA explains that endoleaks can occur after repair with any endovascular graft and typically do not result in symptoms. “If left undetected and without treatment, a Type III endoleak may lead to expansion and rupture of the AAA resulting in serious patient injury, including death,” it says. “Therefore, the FDA strongly recommends, at least yearly, lifelong follow-up visits for all patients implanted with any Endologix AFX endovascular grafts (AFX with Strata, AFX with Duraply or AFX2) with their doctor to ensure the devices are working properly.”

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

Read more

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