LivaNova, UK-based medical technology firm, has introduced the CE-Marked Bi-Flow arterial femoral cannula intended for the prevention of leg ischemia during cardiac surgery.
It is designed as a bidirectional cannula and features a shoulder and downstream perfusion channel to ensure continuous blood flow down the femoral artery. It offers simultaneous systemic and distal perfusion of the cannulated limb. Its open tip design allows adequate systemic perfusion through the whole body.
Leg ischemia develops due to abnormal blood flow to a lower limb and it affects up to 11% patients receiving complex cardiac surgery procedures. This can even lead to higher mortality and morbidity, and longer hospital stays.
In a clinical study it was reported that the new Bi-Flow cannula facilitate easy insertion and removal without any complications. Safe and reproducible perfusion of the limb was also observed with it.
First European procedure using this cannula was performed at the Cardiovascular Center of Bad Neustadt, Germany.
Currently, it is available in markets like European and Canada and is under pre-market notification for the US.
LivaNova plans the expansion of the cannula from existing 19fr size to additional sizes.
Mr Vinod Arora, Principal Advisor, IGMPI
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