Devices

MicroVention PMA OK’d for Neck Aneurysm Device

FDA has approved a MicroVention (a Terumo subsidiary) PMA for the WEB Aneurysm Embolization System for treating intracranial wide neck bifurcation aneurysms. The company says the device is the only PMA-approved device in the new category of intrasaccular flow disruptors for aneurysm embolization. PMA approval is based on data from the WEB-IT pivotal trial where the device demonstrated 84.6% adequate occlusion. The WEB System was developed by Sequent Medical, which Terumo acquired in 2016.

The WEB System is a single-device treatment solution for wide neck bifurcation aneurysms, which may account for up to 35% of all aneurysms, according to the company. When placed inside the aneurysm sac, its proprietary microbraid technology is intended to bridge the aneurysm neck, disrupting blood flow, and creates a scaffold for long-lasting treatment, it explains.

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