LivaNova - Health innovation that matters

The material provided is for information purposes only and may contain information about therapies and products that may not be approved in your country. For further information on product availability, please contact your local representative. Prior to use, please consult your specific product labeling for operating instructions and prescriptive information, including indications, contraindications, warnings, precautions, risks and adverse events.
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Product highlights

Bi-Flow® ECMO – The unique bidirectional cannula is now validated up to 29 days

After a successful first year of experience in the cardiac surgery setting, Bi-Flow is now validated for up to 29 days of use. This unique bidirectional cannula is designed to reduce the risk of limb ischemia in an easy, safe and reproducible way for patients receiving ECMO.

Unlike traditional cannulae, Bi-Flow’s patented design incorporates a unique elbow and downstream perfusion channel. The cannula is easy to insert and remove and provides simultaneous systemic and distal perfusion to the lower limb.
 
Limb ischemia is a potentially life-threatening complication of femoral artery cannulation. It can affect between 10% and 70% of patients undergoing VA-ECMO and may have devastating consequences such as higher mortality, higher morbidity and longer hospital stay.[1]
 
The LivaNova Bi-Flow cannula is designed to reduce this risk[2] in all procedures requiring femoral cannulation. In addition to its unique bidirectional perfusion design, Bi-Flow also offers:
 

  • Simple and straightforward insertion and removal process, both percutaneously using a standard needle and guide wire technique or after a surgical cut-down
  • DOP-free tubing and Ph.I.S.I.O. coating for enhanced biocompatibility
  • Optimal pressure drop level for adequate systemic perfusion
  • Unique fixation device designed to ensure that it remains correctly positioned during the procedure

 
In addition to the ECMO version, Bi-Flow is approved also for cardiopulmonary bypass procedures for periods up to 6-hours, to deliver its benefits to patients undergoing complex cardiac surgery procedures and requiring femoral cannulation.
 


[1] Bonicolini et al. Limb ischemia in peripheral veno-arterial extracorporeal membrane oxygenation: a narrative review of incidence, prevention, monitoring, and treatment. Critical Care (2019) 23:266
 
[2] Marasco et al. Innovations (Phila). 2018 Mar/Apr;13(2):97-103

Not approved in all geographies. For further information on product availability, please contact your local representative. For indications, contraindications, precautions and warnings for each device, please refer to the Instructions For Use.

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