Abstract
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.
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