Devices

Letter to MDs Updates Advice on Neurovascular Stents

A new FDA letter to healthcare professionals provides recommendations about patient selection and the use of neurovascular stents used for stent-assisted coiling (SAC) of brain aneurysms. The agency says it has received reports associated with the use of these devices in treating unruptured brain aneurysms that “suggest some events of peri-procedural stroke and/or death may have been related to procedural risks or patient selection related factors. These factors include patients who had serious co-morbidities resulting in a reduced life expectancy, or who were intolerant to required anticoagulation or anti-platelet therapy.”

Neurovascular stents used for SAC, according to FDA, are intended to treat wide-neck, intracranial, saccular aneurysms arising from various sized parent vessel diameters depending on the manufacturers’ intended use. “Many patients with unruptured brain aneurysms can be managed conservatively with routine monitoring and follow-up depending on their individual risk factors for aneurysm rupture,” the agency says.

In its recommendations, FDA says physicians should consider and discuss with patients the benefits and risks of neurovascular stent devices and procedures, as well as the availability of any alternative management modalities. “For smaller brain aneurysms, or for patients with reduced life expectancy, in the absence of other risk factors, the risks of treatment may outweigh the benefits of treatment,” it notes. “Therefore, the patient should be properly informed of the rates of serious adverse events and the rupture risk as part of the decision making to undergo intervention.”

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