Total Flow Medical has successfully completed enrollment of its 10-patient First Human study using the Total Flow Medical femoral arterial cannula. In this study, ten procedures were conducted utilizing the cannula to help maintain distal perfusion of the cannulated limb during minimally invasive mitral valve surgery with cardiopulmonary bypass (CPB). All ten procedures were conducted at Calgary’s Foothills Medical Centre by Dr. William Kent and Dr. Corey Adams.
All procedures were conducted successfully with no device-related adverse events observed. The required 30-day follow-up has been completed for over half of the 10 enrolled patients, with completion of follow-up on the remaining patients expected over the coming weeks. This meaningful step in the company’s trajectory further demonstrates the performance and clinical value of the device, which provides the option of distal limb perfusion in a single cannula.