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New concept of stent, the Multilayer Flow Modulator has been developed to treat arterial aneurysms

Traditional treatment of arterial aneurysms has been surgical. However, interventional procedures even with a high technical success rate do not solve issues such as protection of aneurysm rupture, endoleaks, stent thrombosis, collateral branch thrombosis. Addressing this issue, Dr. Michel Henry and coworkers performed the present first in human study that developed a new concept of stent, the Multilayer Flow Modulator, a 3D braided tube made of several interconnected layers without any covering in the treatment of arterial aneurysms and attempted to avoid the few drawbacks encountered with endografts.

Moreover, researchers’ early results of in vitro (theorical simulation), computerized Fluid dynamics, Molecular Modelization and in vivo tests demonstrated Multilayer Flow Modulator to reduce the velocity in the aneurismal sac up to 90% by the modification of the hemodynamic conditions. Some other studies had also shown that a saccular aneurysm without collateral branch to thrombose quickly and also indicated that in the presence of a collateral branch, the flow is directed towards this branch leading to shrinkage of the aneurysm.  

Moreover, as demonstrated in animal and human studies, MFM preserved the collateral branches that allowed the possibility to cover any artery without a compromise in the flow (renal, digestive arteries, supra aortic vessels).

As a part of this study, a total of 39 peripheral Arterial aneurysms (iliac: 23, femoral:1, popliteal:5, renal:8, mesenteric:1, Subclavian: 1) were treated with the MFM* stents (males :30, mean age:  62±8 yrs, 51 stents with diameters 5 to 14 mm; length 40 to 120 mm) to treat these aneurysms, by femoral approach (38 cases), brachial approach (1 case),

All patients reported a technical success without complications. Additionally, all the arterial aneurysms thrombosed with a diameter reduction reported in some patients.

It was found that the time taken for thrombosis depended upon the importance of collateral branches and all the side branches remained patent.

In conclusion, this new concept of stent, the MFM* (without any covering) developed to treat arterial aneurysms with promising results opened a new approach in the treatment of peripheral Arterial aneurysms avoiding most of the complications encountered with current endovascular techniques. A larger study is still ongoing and 6 month to 36 month follow up data presented would discuss the time needed to achieve exclusion of the Arterial aneurysms.

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Source:TCT 2012
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