Total Flow Medical Wins FDA Nod for Femoral Arterial Cannula for Bypass

Total Flow Medical, a company developing solutions for extracorporeal circulation, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Total Flow Medical Femoral Arterial (TFA) cannula.

The femoral arterial cannula is indicated for extracorporeal circulation during cardiopulmonary bypass procedures for up to six hours. The device has a balloon at its distal tip to allow blood flow to the cannulated limb.

Femoral arterial cannulation is widely used for extracorporeal circulation during cardiac surgery, but maintaining blood flow to the cannulated limb remains a challenge. The TFA cannula is designed to address this need while integrating into existing surgical workflows.

After FDA clearance, the Vancouver-based company will prepare for U.S. market release and work with cardiac surgery centers to support early clinical adoption.

“FDA clearance for the TFA Cannula represents a pivotal milestone for Total Flow Medical,” said Hillary Pierce, CEO 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.”