Percutaneous femoral arteriotomy repair -- initial experience with a novel staple closure device

The Vascular Closure System (EVS ) is the first device to utilize a staple mechanism to close percutaneous femoral arteriotomies following catheter-based procedures. To assess safety and efficacy, the EVS was used to close 89 consecutive femoral arteriotomies. Closure success was defined as complete cessation of bleeding within five minutes of staple delivery. The overall closure success rate was 92.1% (n = 82). Mean time to complete hemostasis was 2.47 1.42 minutes. No complication (re-bleeding, pseudoaneurysm, transfusion, arteriovenous fistula, infection or decrease in distal pulses) occurred at 24-hour and 7-day follow-up. We conclude that staple-based technology provides a safe and useful method for mechanical closure of percutaneous femoral arteriotomies.