Bi-Flow, which secured CE Mark earlier this year, marks the only bidirectional arterial cannula designed to prevent leg ischemia during cardiac surgery procedures requiring femoral artery cannulation.

According to a clinical study, Bi-Flow provides simultaneous systemic and distal perfusion of the limb in a safe and reproducible way and can be easily inserted and removed without complications.

Caused by improper blood flow to the lower limb, leg ischemia is set to affect up to 11% of patients undergoing complex cardiac surgery procedures, and may result in higher mortality, higher morbidity and longer hospital stays.

Dr. Patrick Perier from the Cardiovascular Center of Bad Neustadt, Germany has performed the first procedure using Bi-Flow cannula in Europe.

Dr. Perier said: “I truly believe that Bi-Flow has the potential to become the new standard of care to prevent limb ischemia and its devastating effects in complex cases requiring femoral cannulation.

“Where other approaches act as mere workarounds, Bi-Flow ensures leg perfusion and through its unique features allows us to protect the leg in a safe, easy and reproducible way, further improving patient outcomes.”

LivaNova said that it’s advanced, patented bidirectional cannula design includes a unique shoulder and downstream perfusion channel to enable continuous and reliable blood flow down the femoral artery, and the open tip ensures required systemic perfusion for the whole body.

The company has made the Bi-Flow cannula available in Europe, Canada and other select countries in 19fr single size, and is currently in pre-market notification for the US.

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.”

The company is planning to expand the Bi-Flow line next year with more sizes and a version for extracorporeal life support.