In a multi-center, prospective randomized trial, VASCADE demonstrated rapid hemostasis and low complication rates. In this trial, there were no major complications and the incidence of minor complications was significantly reduced as compared to manual compression.1
VASCADE is the only extravascular closure device to offer collagen and a dual method of action, mechanical and physiological. The collagen patch provides a tamponade as a result of rapid expansion of the implant in the presence of fluid. This action ensures the tissue tract is sufficiently filled and provides mechanical hemostasis. The natural thrombogenic property of collagen accelerates coagulation to produce physiological hemostasis.
Multi-center, prospective, randomized trial of 420 patients across 21 centers (20 in the US and 1 in Australia). Subjects were randomly assigned in a 2:1 ratio VASCADE to MC. 81% of VASCADE cases reported pre-procedure anticoagulant and/or antiplatelet administration. Of note, 8% of VASCADE cases had peri-procedural GP IIb/IIIa inhibitors and 77% of IX VASCADE cases were administered bivalirudin.
In Vitro testing demonstrated VASCADE collagen decreases clotting time in both heparinized and non-heparinized blood when compared against control.5