Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
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Multicenter Study
When not to implant the multilayer flow modulator: lessons learned from application outside the indications for use in patients with thoracoabdominal pathologies.
To scrutinize registry data on thoracoabdominal repairs performed using the Multilayer Flow Modulator (MFM) outside the indications for use (IFU) and analyze the adverse outcomes. ⋯ There are clinical scenarios in which the MFM does not perform well. The MFM is not a solution for patients living on borrowed time and should not be used indiscriminately in patients in whom other modalities of aortic repair are not feasible. Its use must adhere to the IFU, and robust clinical data are required before constructing a randomized controlled trial.