Background Endovascular stenting for wide necked aneurysms has become common practice since the release of the Neuroform and more recently the Enterprise stent systems. However, intrinsic to their design, these devices are indicated for the treatment of side wall aneurysm morphologies. We present a novel neck bridge device that recently received HUD approval that simulates a stent for the treatment of bifurcation aneurysms.
Methods This novel neck bridge device composed of several nitinol wires formed to create a virtual saddle shape that covers the ostium of a bifurcation or terminal configuration aneurysm. The device is designed to deliver through a 0.021″ microcatheter and is resheathable/recaptureable up until detachment so it can be used temporarily or detached and left permanently. Multiple human basilar wide necked aneurysms were mechanically simulated in a silicone benchtop model. The device was deployed across the aneurysm ostium and detached. Then an SL-10 microcatheter was advanced across the neck bridge device and into the aneurysm, and aneurysm coiling performed using standard techniques. Next, these same steps were repeated in two experimentally created bifurcation aneurysms in canines. These animals were then survived for 60 days and explanted. Further animal work is currently underway and those results will be presented if available.
Results The saddle neck bridge device was able to be successfully and easily deployed across the aneurysm neck in all instances. All aneurysms were able to be catheterized and coiled without difficulty. In no instance was there prolapse of coil loops through or around the device. Histologic evaluation demonstrated neoendothelial growth over the device struts without evidence of overt or abnormal inflammation or vessel trauma.
Conclusion The saddle neck bridge device is a novel endovascular stent like device that is designed to treat bifurcation aneurysms. Preliminary benchtop and animal modeling demonstrate the device to be safe and feasible for bifurcation aneurysm treatment. It is likely that this device in combination with coils will allow treatment of many aneurysms not treatable by coils alone.
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Competing interests ST—Pulsar Vascular; AT—Boston Scientific, NFocus, Pulsar Vascular, Biomerix.