A novel device for distal fixation of a guidewire was tested in regards to deployment and retrieval, deposition in the blood stream and force of fixation in a pig model. Eleven pigs were subjected to full anaesthesia and heparinized to active clotting time 250–350 s. Uninterrupted blood flow during 4 h deposition was assessed by angiography and inspected for thrombus deposition upon retrieval. The force of fixation was investigated up to the level of loss of fixation (displacement force). The device was successfully deployed and retrieved in over 40 cases. In one case, an alternative method for bailout retrieval was used. Deposition for 4 h was performed, and uninterrupted blood flow was verified by angiography. No instances of arterial occlusion or thrombosis were detected. The median dislocation force was 7.6 N. No arterial rupture or dissection was detected following the loss of fixation. As a conclusion, the device was considered safe and functional in this animal test model.
Objective By using a guidewire fixator, the distal guidewire position can be secured in an artery. This new principle enables a method for fenestrated endovascular aortic repair where the connection between the aortic branches and the stent graft fenestrations is made before inserting and deploying the stent graft. Methods This is conducted using a fenestrated stent graft with preloaded catheters, through which the prepositioned and distally secured guidewires from the branches are inserted. Results This report covers the method when implementing a single fenestration stent graft in pig. Conclusions Successful tests with single and dual fenestrated grafts have been conducted in pigs.
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