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Wang, D HJ1; Fonger, J D2; Kopilec, D1; Magovern, J A3; O'Callaghan, K4; Smith, D E1

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Placement of a cannula in the femoral artery is associated with reduction of distal flow due to occlusion of the lumen. If this reduction is severe, it ultimately causes distal limb ischemia. To solve this problem, a Distal Flow Cannula (DFC) was designed with a distal perfusion hole located in the middle to facilitate distal flow. The performance of different designs with various sized distal perfusion holes and with/without supporting rails was tested on bench top. The preferred design was selected based on testing data. The performance and functionality of the preferred DFC design prototypes were evaluated in six pigs against the performance and functionality of BioMedicus Femoral Arterial Cannula. DFC was implanted in the femoral artery of one leg, the same sized Biomedicus cannula was implanted in the femoral artery of the other. The native flows in the vessels were measured before the cannulae were implanted. Distal flow performance of each cannula was measured under different flow conditions using Transonic flow probes. The results showed excellent distal flow in all DFCs (69% of the native flow, with mean of 0.068 LPM and standard deviation of 0.030 LPM). Statistical analysis showed DFC provides significantly more distal flow than BioMedicus Cannula (p <0.05). There was no difficulty in device placement and removal. No bleeding or other adverse effects were observed while the device was in place. Explant analysis showed no tissue damage to the vessels caused by DFC. A DFC has been successfully developed which can be used to reduce the risk of distal limb ischemia.

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