LivaNova has launched its arterial femoral cannula, Bi-Flow, onto the market. The catheter, which received the CE mark earlier this year, is designed to prevent limb ischaemia during cardiac surgery that requires femoral artery cannulation. In a clinical study, a press release states, Bi-Flow was easily inserted and removed without complications and was proven to provide simultaneous systemic and distal perfusion of the limb in a safe and reproducible way.
The press release explains that the patented and award-winning design of the bidirectional cannula incorporates a unique shoulder and downstream perfusion channel that enables continuous and reliable blood flow down the femoral artery. At the same time, an open tip design ensures adequate systemic perfusion for the whole body.
The first procedure in Europe using a Bi-Flow cannula was performed by Patrick Perier (Cardiovascular Centre, Bad Neustadt, Germany). He says: “I truly believe that Bi-Flow has the potential to become the new standard of care to prevent limb ischaemia 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.”
Alistair Simpson, LivaNova general manager of Cardiac Surgery, states: “Limb ischaemia 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.”
Bi-Flow is now available in Europe, Canada and other select countries in one size (19fr), and is currently in pre-market notification for the USA. LivaNova plan to expand the line next year with more sizes and a version validated for Extracorporeal Life Support to address long-term procedures.