Safety and Efficacy Profile of Off-Label Use of the Pipeline Embolization Device: A Systematic Review and Meta-Analysis

It has been more than ten years since the initial Food and Drug Administration (FDA) approved the first flow diverters (FDs) for treating brain aneurysms.1 The approval of these devices was made possible due to the safety and efficacy demonstrated in both the single-arm Pipeline Embolization Device(PED) for the intracranial treatment of aneurysm trial2 and the Pipeline for Uncoilable or Failed aneurysms (PUFs) trial.3,4 The FDA initially approved the indications for the flow diverters based on the inclusion criteria of the PED for the intracranial treatment of aneurysms trial (PITA) and extrapolated from its results.

Source: Journal of Stroke and Cerebrovascular Diseases - January 17, 2024 Category: Neurology Authors: Yigit Can Senol, Atakan Orscelik, Cem Bilgin, Hassan Kobbeisi, Sherief Ghozy, Santhosh Arul, David F Kallmes, Ramanathan Kadirvel Source Type: research