LivaNova Bi-Flow Cannula Receives CE Mark for ECMO Applications

LivaNova PLC, a medical technology and innovation company, announced its Bi-Flow Extracorporeal Membrane Oxygenation (ECMO) cannula earned CE Mark approval for ECMO 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.¹
 
“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.”
 
Bi-Flow ECMO comes with a unique fixation device designed to ensure that it remains correctly positioned and to prevent dislocation due to patient movement. Its design is intended for longer term use and includes no-DOP tubing and PH.I.S.I.O. coating to improve biocompatibility, along with a tip designed to ensure adequate perfusion with low risk of hemolysis.
 
Recognized by the European Association for Cardio-Thoracic Surgery (EACTS) with the Techno-College Innovation Award in 2018, the original Bi-Flow is currently available in Europe, Canada and other select countries in one size (19 fr) for cardiac surgery. Bi-Flow ECMO is now in limited release and will soon become fully available in Europe and select countries.
 
References
¹ Marasco et al., A Phase 1 Study of a Novel Bidirectional Perfusion Cannula in Patients Undergoing Femoral Cannulation for Cardiac Surgery, Innovations, 2018.