Devices

FDA Reviews Catheter Use Differences

In a letter to healthcare providers, CDRH says it is aware of marketing materials and recently published literature that imply a new intended use for some neurovascular guide catheters for neurovascular thrombosis removal in patients with acute ischemic stroke. The letter says that FDA has not cleared neurovascular guide catheters for that indication.

“Healthcare providers are encouraged to carefully consider the information provided [in the letter] explaining the FDA cleared intended use when reading marketing materials and literature provided for guide catheters,” the letter says. “It is also important for healthcare providers to be aware of and consider the differences in device design between cleared neurovascular guide catheters and neurovascular thrombus retrieval catheters and the potential implications those differences may have during certain uses, especially in the more distal regions of the neurovasculature.”

A chart in the letter gives the product code, indication, and performance data for thrombus retrieval catheters and guide catheters. It notes that the two types may be designed with different features, such as length, diameter, and variations in material stiffness distally and proximally. “Use of neurovascular guide catheters for thrombus removal may affect the safety and performance, which could result in device failure and/or serious adverse events such as vessel damage, perforation, or dissection when used in the most distal regions of the neurovasculature,” it cautions.

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