Drugs

Medtronic Unit Recalls Brain Aneurysm Stents

Medtronic’s Micro Therapeutics unit (dba ev3 Neurovascular) has begun a Class 1 recall of its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology due to the risk that its delivery system wire and tubes could fracture and break off inside a patient. Attempts to retrieve the fractured pieces may make a patient’s condition worse, and fragments left in the bloodstream can cause other serious adverse health consequences such as continued blockage of blood vessels, stroke, and death, a recall notice says. FDA says there have been 59 reported device malfunctions, 10 serious injuries, and two deaths related to this issue. The devices are permanent mesh stents intended for treating brain aneurysms that bulge or balloon out the sides of the blood vessel (wide-neck and fusiform).

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