Devices

FDA Safety Alert on Endovascular Graft Systems Leaks

FDA is alerting vascular surgeons about concerns regarding Type IIIa and IIIb endoleaks with the use of endovascular graft systems indicated for aneurysm repair procedures that treat abdominal aortic aneurysms and aorto-iliac aneurysms. In a 9/28 letter to healthcare professionals, FDA says recent information from several sources suggests an increase in the occurrence of Type III endoleaks. “This increase is compared to earlier clinical update reports in patients with various device models and implant duration lengths, including some patients who had previously stable repairs,” the agency letter says. “We are bringing this potential complication to your attention to remind and encourage you to report Type IIIa and IIIb endoleak events to the manufacturer and the FDA. This may include reporting individual events as well as rates you may have experienced in your practice.”

FDA considers a Type III endoleak a device-related event that requires treatment with additional interventions such as re-lining, insertion of additional endograft components, or open surgical repair. “Predictors of Type III endoleak may include treatment with early generation graft materials, the presence of calcified plaque, and inadequate overlap between components,” it 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