Total Flow Medical announced today that it received FDA 510(k) clearance for its TFA femoral arterial cannula device.
Vancouver-based Total Flow Medical’s TFA cannula received clearance for extracorporeal circulation during cardiopulmonary bypass procedures for up to six hours.
Femoral arterial cannulation, a commonly used technique for establishing extracorporeal circulation, circulates blood outside the body during cardiac surgery. However, the company says maintaining blood flow to the cannulated limb remains an important consideration.
Total Flow Medical designed the TFA cannula with this challenge in mind. The device incorporates a balloon at its distal tip to allow blood flow to the cannulated limb. According to the company, it provides clinicians with an option that can integrate into existing surgical workflows as well.
With clearance, Total Flow Medical has preparations underway for a U.S. market release. It plans to 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 CEO Hillary Pierce. “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.”
