Abstract
Background: The Multilayer Flow Modulator (MFM) (Cardiatis, Isnes, Belgium) is a self-expandable mesh of cobalt alloy wires used for the treatment of aortic aneurysms. The impact of design thread count and duration of implantation on the biocompatibility of the MFM in porcine animal models was assessed in this study. Methods: Eight mini-piglets received 26 MFM devices (12 with 56 threads, 14 with 80-96 threads) in the iliac, carotid, and renal arteries. Animals were sacrificed and specimens explanted at 1, 3, and 6 months, at which time histological and ultrastructural analyses were carried out. Results: The MFM was successfully deployed in 25 of the 26 implanted cases. The 56 thread devices were well tolerated locally and yielded fewer signs of inflammation and neo intimal hyperplasia. Percentage stenosis was 16.9% ± 5.1% for the 56 thread devices versus 33.4% ± 10.2% for the 80-96 thread devices (p=0.001) at 3 months, and 21.7% ± 9.9% for the 56 thread devices versus 33.6% ± 12.4% for the 80-96 thread devices (p=0.004) at 6 months. The 5 devices selected for SEM examination were well deployed, integrated into the vessel wall and endothelialized, and had patent side branches. Conclusions: No significant stenosis formation or inflammatory response was recorded in any of the implanted animals. The 80-96 thread devices elicited a greater intra-arterial response than the 56 thread devices, although the values for both groups remained within the normal range for stented carotid, renal, or iliac arteries. Further preclinical and clinical studies will extend assessment of the long-term safety and effectiveness of the MFM
Highlights
Total exclusion of the aneurysm sac is the typical aim when stent grafts are deployed during endovascular repair
While a slight narrowing was observed in the distal sections of devices 11 and 12 in animal C, they were not inflated via angioplasty
This study assessed the biocompatibility of the Multilayer Flow Modulator (MFM) device in porcine animal models, focusing on the differential impact of design thread count and duration of device implantation
Summary
Total exclusion of the aneurysm sac is the typical aim when stent grafts are deployed during endovascular repair. In treatment of thoraco abdominal aortic pathologies that would involve coverage of visceral arteries, fenestration holes and branching stent-grafts are placed in the endografts to allow for collateral branch flow [1]. An alternative approach to management of aortic aneurysms involves disruptive technology, in the form of the Multilayer Flow Modulator (MFM) (Cardiatis, Isnes, Belgium) [3]. The MFM design allows blood flow through the mesh in a manner that maintains collateral branch patency, while modulating the flow from turbulent to laminar within the device and the aneurysm sac. The MFM could represent a viable treatment alternative in complex arterial pathologies and in situations where open surgery or endovascular repair using a branched or fenestrated graft would not be feasible. The Multilayer Flow Modulator (MFM) (Cardiatis, Isnes, Belgium) is a self-expandable mesh of cobalt alloy wires used for the treatment of aortic aneurysms. The impact of design thread count and duration of implantation on the biocompatibility of the MFM in porcine animal models was assessed in this study
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