Devices

FDA Early Alert Over Boston Scientific Transcarotid Catheter Systems

FDA has issued an early alert warning healthcare providers about a potentially high-risk issue involving certain lots of Boston Scientific's ENROUTE Transcarotid Neuroprotection System (NPS) and ENROUTE Transcarotid Neuroprotection System Plus (NPS Plus), following reports that the arterial sheath tip can separate during use.

The agency said Boston Scientific notified affected customers on 7/9 to immediately stop using and distributing the affected devices, segregate existing inventory, and return the products to the company. Customers were also instructed to notify personnel who use the devices and inform any facilities that may have received the affected products.

According to the agency, a retained sheath tip may require endovascular or surgical retrieval and could lead to serious complications, including embolism, stroke, transient ischemic attack, restenosis, or thrombosis. Boston Scientific has reported one serious injury linked to the issue and no deaths.

The device is used during transcarotid artery revascularization procedures to reduce the risk of stroke by temporarily reversing blood flow in the carotid artery, diverting embolic material away from the brain while physicians treat carotid artery lesions.

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

Read more

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