LONDON--(BUSINESS WIRE)--LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today launched its innovative arterial femoral cannula, Bi-Flow, designed to prevent limb ischemia during cardiac surgery.
LivaNova Bi-Flow received CE Mark earlier this year and is the only bidirectional arterial cannula designed to prevent leg ischemia during cardiac surgery procedures requiring femoral artery cannulation. In a clinical study, 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
Leg ischemia is caused by compromised blood flow to a lower limb and can affect up to 11% of patients undergoing complex cardiac surgery procedures.2 Consequences can include higher mortality, higher morbidity and longer hospital stays.3
The first procedure in Europe using a Bi-Flow cannula was performed by Patrick Perier M.D., FACS, at the Cardiovascular Center of Bad Neustadt, Germany. “I truly believe that Bi-Flow has the potential to become the new standard of care to prevent limb ischemia and its devastating effects in complex cases requiring femoral cannulation,” said Dr. Perier. “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.”
The innovative, 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.
“Limb ischemia is an often-underestimated potential side effect of femoral artery cannulation, and it can have dramatic consequences,” said Alistair Simpson, LivaNova General Manager of Cardiac Surgery. “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 (19 fr), and is currently in pre-market notification for the U.S. The line will expand next year with more sizes and a version validated for Extracorporeal Life Support to address long-term procedures.
For more information on the Bi-Flow bidirectional cannula, visit www.bi-flow.livanova.com.
Important Safety Information
For professional use. Please contact LivaNova through the Company website to receive instructions for use containing full prescribing information, including indications, contraindications, warnings, precautions and adverse events. Not approved in all geographies. Consult your labeling.
LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. LivaNova’s advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems. Headquartered in London, LivaNova has a presence in more than 100 countries worldwide. The Company currently employs approximately 4,000 employees. LivaNova operates as two businesses: Cardiovascular and Neuromodulation, with operating headquarters in Mirandola (Italy) and Houston (U.S.), respectively.
For more information, please visit www.livanova.com.
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1. Marasco et al., A Phase 1 Study of a Novel Bidirectional Perfusion Cannula in Patients Undergoing Femoral Cannulation for Cardiac Surgery, Innovations, 2018
2. Hendrickson et al., A Method for Perfusion of the Leg During Cardiopulmonary Bypass via Femoral Cannulation, Ann Thorac Surg. 1998 Jun;65(6):1807-8
3. June et al., Acute Limb Ischemia After Cardiothoracic Surgery Is Associated With High Rates of Amputation and Mortality, Journal of Vascular surgery, 2015