A Pilot Study of the Intracranial Multilayer Flow Modulator as a New Disruptive Technology in the Treatment of Cerebral Aneurysms
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Abstract
The purpose of this study was to evaluate by histopathological analysis and Energy Dispersive X-ray analysis, the ability to occlude cerebral aneurysms with the Cardiatis (Isnes, Belgium) intracranial Multilayer Flow Modulator (MFM) device.
The devices were implanted in the subclavian artery distally to the brachiocephalic trunk proximally of 6 rabbit animal models, following induction of an aneurysm in the right carotid artery, collateral to the implanted segment of the subclavian. Device placement was performed 4 weeks after aneurysm creation, and for an implantation duration of 4 weeks. The aim of the study was to demonstrate local biocompatibility of the device as well as device integration without signs of complication.
Gross examination and histopathological analysis showed the aneurysmal areas of all six specimens were obturated with an old mixed thrombus, showing the lines of Zahn. The devices were also markedly integrated into the arterial wall with no evidence of local intolerance, and no aneurysm rupture or leakage was observed. Energy dispersive x-ray analysis of the specimens revealed that in all areas investigated in the tissues surrounding the device struts, there was an absence of metal release.
These results demonstrate the basic mechanism of the MFM, its ability to occlude a cerebral aneurysm, created using a rabbit model. Studies using a larger cohort and longer time period are necessary to assess the intracranial MFM’s long-term results.
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