Devices

FDA Updates Alert on Endovascular Graft Systems

FDA says it continues to evaluate information from several sources, including endovascular graft system manufacturers, about the risks associated with Type III endoleaks with various aortic endovascular graft systems indicated for treating abdominal aortic aneurysms and aorto-iliac aneurysms. In 9/2017, an FDA letter to health care providers alerted them about an increase in the occurrence of Type III endoleaks with the use of these devices for aneurysm repair. Since that alert and based on new information, the increased risk for Type III endoleak appears to be specific to one device at this time — the Endologix AFX with Strata device.

FDA says Endologix has not manufactured the graft material since July 2014, and in December 2016 it requested that all AFX with Strata devices be removed from hospital inventory. Because there are patients that have previously been implanted with the device, the agency is recommending that physicians closely monitor patients who have the AFX with Strata device, and ensure annual follow-up at a minimum to monitor for Type III endoleaks.

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