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Heart Surgery Device Gets FDA Green Light
31 Jul
Summary
- FDA clearance granted for a novel femoral arterial cannula.
- Device designed for adult patients with specific artery diameter.
- Cannula aims to improve limb perfusion during bypass procedures.
Total Flow Medical has received 510(k) clearance from the US FDA for its novel TFA cannula. This device is intended for use in cardiopulmonary bypass procedures in adult patients, with a maximum duration of six hours.
The TFA cannula features a unique design with a balloon at its distal tip. This aims to ensure blood flow to the cannulated limb throughout surgical interventions.
Femoral arterial cannulation is a standard practice in cardiac surgery for extracorporeal circulation. However, maintaining adequate limb perfusion has been a persistent challenge.
Total Flow Medical plans to collaborate with US cardiac surgery centers to facilitate the early clinical adoption of this device. The company is preparing for a US market launch following this significant FDA clearance.
