Total Flow Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its femoral arterial cannula, intended for use in cardiopulmonary bypass procedures.
The device is indicated for extracorporeal circulation in adult patients and can be used for procedures lasting up to six hours.
The TFA cannula includes a balloon at its distal tip designed to allow flow of blood to the cannulated limb during procedures.
Femoral arterial cannulation is commonly employed in cardiac surgery to establish extracorporeal circulation, but maintaining limb perfusion remains a key consideration for surgical and perfusion teams.
The TFA cannula is intended to address this aspect while integrating into established clinical workflows.
Total Flow Medical will work with cardiac surgery centres in the US to support early clinical adoption.
Total Flow Medical CEO Hillary Pierce said: “FDA clearance for the TFA Cannula represents a pivotal milestone for 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 US.”
The cannula is designed for use in adult patients with a common femoral artery diameter of 7.5mm or greater.
It cannulates blood vessels and is intended to be connected with accessory equipment for extracorporeal circulation. The introducer assists with correct placement of the cannula into the vessel during bypass procedures.
Total Flow Medical states its development efforts focus on solutions for extracorporeal circulation that integrate into existing clinical practice. The company is preparing for a US market launch of the TFA cannula following the FDA clearance.
