Abstract

This study tested the hypothesis that the Multilayer Flow Modulator (Cardiatis, Isnes, Brussels) can treat aortic aneurysms through intra-arterial hemodynamic modulation, without substantial parent or small branch artery compromise, using 8 porcine models. The animals were euthanized and devices explanted upon completion of the study for examination. Results of the delivery system evaluation showed that there were no difficulties during navigation of the device through the arteries. An overall trend of reduction in aneurysm size was recorded. The opening of the aneurysm was nearly occluded with thrombus in 2 of the explants. The visceral arteries covered by the device remained patent, and it adhered to the arterial wall with endothelialization clearly visible. The MFM was therefore placed without intra-arterial compromise, and the aneurysms were stabilized while adequate blood flow to the collateral arteries was preserved.

Highlights

  • Total exclusion of the aneurysm sac is common practice with traditional endovascular grafts in some cases fenestration holes are placed in the grafts to allow for collateral branch flow. [1] Despite such advances in endovascular repair, it has been suggested that, as a challenge inherent to the use of covered stents, total exclusion of the aneurysm may subject the sac to increased pressure and risk of rupture. [2,3] exclusion of the sac often leads to visceral hemodynamic compromise, and inadequate perfusion to peripheral organs, often when collateral arteries feed the aneurysm.An alternative approach to the management of aortic aneurysms that has recently emerged involves a disruptive technology, in the form of Multilayer Flow Modulator (MFM) (Cardiatis, Isnes, Brussels)

  • This study evaluated the performance of the MFM in 8 porcine test animals, with aneurysms experimentally induced by grafting of venous tissue onto the abdominal aorta

  • Our results showed that the aneurysms were stabilized, since there was no increase in their size over the duration of the study

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Summary

Introduction

Total exclusion of the aneurysm sac is common practice with traditional endovascular grafts in some cases fenestration holes are placed in the grafts to allow for collateral branch flow. [1] Despite such advances in endovascular repair, it has been suggested that, as a challenge inherent to the use of covered stents, total exclusion of the aneurysm may subject the sac to increased pressure and risk of rupture. [2,3] exclusion of the sac often leads to visceral hemodynamic compromise, and inadequate perfusion to peripheral organs, often when collateral arteries feed the aneurysm.An alternative approach to the management of aortic aneurysms that has recently emerged involves a disruptive technology, in the form of Multilayer Flow Modulator (MFM) (Cardiatis, Isnes, Brussels). Total exclusion of the aneurysm sac is common practice with traditional endovascular grafts in some cases fenestration holes are placed in the grafts to allow for collateral branch flow. Branched and fenestrated graft technologies have not posed any significant advantages over traditional methods They prove to be considerably more difficult for the operator to utilize, and require greater pre-operative preparation in terms of artery and aneurysm morphologies. [4] The MFM received Conformité Européenne (CE) marking in Europe in October 2010 for use in aortic aneurysm repair. Many of these devices have been placed in patients on compassionate grounds, but there has been little in vivo documentation of the MFM mechanism of action

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