Devices

Endologix Restricts Nellix Stent Graft

Endologix says it is discontinuing unrestricted sales of its Nellix stent graft for treating abdominal aortic aneurysms and limiting its use to pre-screened patients under a clinical protocol. The company is recalling all existing inventory data, and use under the protocol will first be pre-screened by a panel of doctors and supported by the company’s clinical specialists, Endologix says. The recall and limited use order is based on concerns raised in publications about suboptimal outcomes when the device is used outside current instructions for use, it adds.

“Ensuring patient safety and optimal clinical outcomes is our top priority, and the current level of off-label use of the Nellix system cannot continue if we are to protect and preserve the potential for transformative endovascular aneurysm sealing therapy,” Endologix says. “Taking these actions aligns with clinical practice standards, allows us to control off-label use and will help us ensure appropriate application of the therapy.”

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