Novel vascular sealing device for closure of percutaneous vascular access sites.

To investigate the hemostatic capabilities of a novel vascular sealing device consisting of a balloon catheter and procoagulant, vascular sheaths were placed percutaneously in the femoral arteries of dogs. The sealing device was evaluated using the balloon catheter alone in six femoral arteries and with the addition of a procoagulant, in 21 femoral arteries. The balloon catheter alone was successfully deployed in six of six femoral arteries achieving immediate hemostasis. In a second study in which the procoagulant was delivered following balloon placement, the sealing device was successfully deployed and hemostasis was achieved in 20 of 21 attempts (95%) despite removal of the balloon catheter. In a subset of fully anticoagulated animals, hemostasis was achieved in the sealing device-treated arteries at 6.5+/-3.4 minutes, but in none of the controls (P < 0.001). This novel vascular sealing device successfully achieves rapid hemostasis in normal and anticoagulated dogs following percutaneous vascular procedures.