FDA Flow Diverter Tech Topic of April Meeting
The FDA’s Neurological Devices Panel will meet April 17 to discuss clinical trial considerations for flow diverters that are intended to treat brain aneurysms. The focus will be on study design and conduct and how to evaluate clinical date for the technology, according to today’s Federal Register.
Flow diverters are an endoluminal treatment option for intracranial aneurysms. Their design includes a significantly higher density of mesh than traditional stents, which is thought aid in clotting and sealing of aneurysms by reducing the incoming blood flow. They are especially useful for treating large or giant wide-neck aneurysms, the FDA says.
Plymouth, Minn.-based ev3’s Pipeline Embolization Device was the first flow diverter to garner FDA approval in 2011.
View the meeting notice at www.fdanews.com/02-24-15-neurology.pdf. — Elizabeth Orr