LivaNova Bi-Flow Cannula Receives CE Mark for extracorporeal membrane oxygenation (ECMO )applications.

LivaNova PLC announced its Bi-Flow Extracorporeal Membrane Oxygenation (ECMO) cannula earned CE Mark approval for ECMO ( Extracorporeal Membrane Oxygenation) procedures where femoral artery cannulation can be applied. Bi-Flow previously received CE Mark in 2019 for cardiac surgery procedures requiring femoral artery cannulation.

Now validated for up to 29 days of use, Bi-Flow ECMO is designed to reduce the risk of limb ischemia for patients receiving ECMO and it allows for safe, easy and reproducible procedures.

“After witnessing the potential of Bi-Flow in the cardiac surgery setting, the availability of the cannula for ECMO applications promises to redefine the standard of care for femoral artery cannulation during extracorporeal life support procedures,” said Dr. Paulo Neves from Centro Hospitalar Vila Nova de Gaia in Portugal. “We are looking forward to having this cannula so we can treat critically ill patients in an effective way.”

Limb ischemia, or tissue damage due to compromised blood flow, is a potentially devastating complication during Extracorporeal Life Support (ECLS). During ECLS procedures such as ECMO, a patient’s blood is externally oxygenated and recirculated through the body to provide circulatory and respiratory support during severe heart, lung or combined heart-lung failure. In a clinical study in a cardiac surgery setting, 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 Bi-Flow ECMO cannula is a truly game-changing technology that is designed to reduce the incidence of limb ischemia during long-term ECMO support,” said Dr. Brian Duncan, Vice President of Medical Affairs at LivaNova. “I see real enthusiasm among clinicians for the availability of Bi-Flow ECMO as a potential solution for this difficult clinical problem.”