The TFA Cannula incorporates a distal balloon feature designed to allow blood flow to the cannulated limb during cardiopulmonary bypass

/PRNewswire/ - Total Flow Medical, a medical device company developing solutions for extracorporeal circulation, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Total Flow Medical Femoral Arterial (TFA) Cannula, a femoral arterial cannula indicated for extracorporeal circulation during cardiopulmonary bypass procedures for up to six hours. The device incorporates a balloon at its distal tip designed to allow blood flow to the cannulated limb.

"FDA clearance for the TFA Cannula represents a pivotal milestone for Total Flow Medical," said Hillary Pierce, Chief Executive Officer of Total Flow Medical. "This device is the product of close collaboration among perfusionists, engineers and cardiac surgeons who set out to reimagine how cardiac surgery teams approach extracorporeal circulation - starting with femoral arterial cannulation. Receiving FDA clearance marks the start of our commercial journey, and we look forward to introducing the TFA Cannula to hospitals across the United States."

Femoral arterial cannulation is a widely used technique for establishing extracorporeal circulation - circulating a patient's blood outside the body - during cardiac surgery, but maintaining blood flow to the cannulated limb remains an important consideration for surgical and perfusion teams. The TFA Cannula was designed with this clinical challenge in mind, providing clinicians with an option that is designed to integrate into existing surgical workflows.

Following FDA clearance, Total Flow Medical is preparing for U.S. market release and will work with cardiac surgery centers to support early clinical adoption.

About the TFA Cannula

The Total Flow Medical Femoral Arterial (TFA) Cannula is indicated for extracorporeal circulation during cardiopulmonary bypass procedures for up to six hours.

About Total Flow Medical

Total Flow Medical is developing solutions for extracorporeal circulation to address unmet clinical needs which integrate into established clinical workflows. Learn more at www.totalflowmedical.com.

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1 The TFA cannula is used to cannulate vessels and connect with accessory extracorporeal equipment. The TFA cannula is intended for adult patients with a common femoral artery diameter that is 7.5mm and greater. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for cardiopulmonary bypass. The TFA cannula is used in the femoral position as an arterial delivery cannula for extracorporeal circulation in cardiopulmonary bypass procedures for up to 6 hours. The TFA cannula features a balloon on its distal tip which may allow for blood flow to the cannulated limb.

SOURCE Total Flow Medical