UK-based medical technology firm LivaNova has introduced the CE-Marked Bi-Flow arterial femoral cannula intended for the prevention of leg ischemia during cardiac surgery.
Designed as a bidirectional cannula, Bi-Flow 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.
It also comes with an open tip design to allow adequate systemic perfusion through the whole body.
Leg ischemia, which affects up to 11% of patients receiving complex cardiac surgery procedures, develops due to abnormal blood flow to a lower limb. The condition can lead to higher mortality and morbidity, and longer hospital stays.
In a clinical study, the new Bi-Flow cannula was reported to facilitate easy insertion and removal without any complications. It allowed safe and reproducible perfusion of the limb.
The first European procedure using the cannula was performed at the Cardiovascular Center of Bad Neustadt, Germany.
LivaNova Cardiac Surgery general manager Alistair Simpson said: “Limb ischemia is an often-underestimated potential side effect of femoral artery cannulation, and it can have dramatic consequences.
“We are proud to launch this innovative cannula that offers a safe and easy way to prevent complications for our patients, especially during minimally invasive, redo and other complex cardiac surgery procedures.”
Currently, the new device is available in certain markets, including Europe and Canada. It is under pre-market notification for the US.
LivaNova plans to expand the cannula from existing 19fr size to additional sizes as well as a version for Extracorporeal Life Support in long-term procedures.
The company also announced the US Food and Drug Administration (FDA) clearance of its LifeSPARC advanced circulatory support pump and controller.
LifeSPARC is designed to provide temporary support for emergent rescue patients in different settings.