Medical device company Total Flow Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its femoral arterial (TFA) cannula, marking a significant milestone in the company’s efforts to advance technologies for cardiac surgery.

The device is approved for use in adult patients undergoing cardiopulmonary bypass procedures that require extracorporeal circulation for up to six hours. The clearance paves the way for the company’s commercial launch in the United States.

Designed to Support Limb Perfusion

The TFA cannula features a balloon integrated into its distal tip, enabling blood flow to the cannulated limb during bypass procedures. Femoral arterial cannulation is widely used in cardiac surgeries to establish extracorporeal circulation, but maintaining adequate blood supply to the affected limb remains an important clinical consideration.

By incorporating this design, Total Flow Medical aims to improve limb perfusion while allowing the device to fit seamlessly into existing surgical and perfusion workflows without requiring significant procedural changes.

The cannula is intended for use in adult patients with a common femoral artery diameter of 7.5 millimeters or greater. It is designed to cannulate blood vessels and connect with standard extracorporeal circulation equipment. An accompanying introducer assists clinicians in accurately positioning the device during bypass procedures.

Commercial Launch Underway

Following FDA clearance, Total Flow Medical plans to collaborate with cardiac surgery centers across the United States to support the early clinical adoption of the TFA cannula. The company expects these partnerships to facilitate physician familiarity and evaluate the device’s performance in real-world clinical settings.

Company Sees Major Milestone

Commenting on the approval, Total Flow Medical CEO Hillary Pierce described the FDA clearance as a pivotal achievement for the company.

According to Pierce, the TFA cannula is the result of close collaboration among perfusionists, engineers, and cardiac surgeons who sought to rethink femoral arterial cannulation and improve the management of extracorporeal circulation. She added that regulatory clearance marks the beginning of the company’s commercial journey and expressed confidence in bringing the technology to hospitals nationwide.

Focus on Innovation in Extracorporeal Circulation

Total Flow Medical continues to focus on developing medical technologies that enhance extracorporeal circulation while integrating with established clinical practices. With regulatory approval now secured, the company is preparing for the nationwide rollout of the TFA cannula, aiming to provide cardiac surgery teams with a new option designed to support both procedural efficiency and patient care during cardiopulmonary bypass.

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