LivaNova - Health innovation that matters

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Clinical Leaflets

Bi-Flow Phase 1 Clinical study

Bi-Flow Arterial Cannula is safe and easy to insert and provides stable distal perfusion of the cannulated limb.

Dr. Marasco’s paper1 demonstrates that the novel bidirectional cannula is safe and easy to insert and provides stable distal perfusion of the cannulated limb in patients undergoing femoral arterial cannulation for CPB during cardiac surgery. It shows how Bi-Flow should largely obviate the need to insert a separate downstream perfusion cannula or use other techniques to protect against lower limb ischemia.

In this phase-1 clinical trial Bi-Flow was inserted and removed without any procedural complications. Continuous stable distal perfusion was demonstrated using NIRS in 14 of 15 patients and in 100% of the cases mean arterial pressure was deemed sufficient to ensure adequate organ perfusion.

 

Silvana F. Marasco, Elli Tutungi, Shirley A. Vallance, Andrew A. Udy, Justin C. Negri, Adam D. Zimmet, David C. McGiffin, Vincent A. Pellegrino, and Randall A. Moshinsky, (2018). Phase 1 Study of a Novel Bidirectional Perfusion Cannula in Patients Undergoing Femoral Cannulation for Cardiac Surgery. Innovations, Volume 13, Number 2, March/April 2018.

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IM-02612 A