Sharing Risk by Sharing Costs

The Vascade Performance Guarantee

Because Cardiva Medical^® is so committed and confident in VASCADE’s^® ability to safely and rapidly achieve hemostasis, we offer a unique value-based purchasing program called the VASCADE^® Performance Guarantee™. In the event of a complication as the result of VASCADE, Cardiva Medical will provide significant financial reimbursement to your hospital or practice. It’s simple, we’re dedicated to exceptional outcomes for you and your patients. We stand behind our product based upon published clinical studies and demonstrated superior performance in the surgical theater.

Very Low Complication Rates, Rapid Hemostasis in Large Multi-Center Trial

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.

RESPECT TRIAL RESULTS Published in the Journal of Invasive Cardiology

RESPECT Trial Chart

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.

VASCADE Achieves Rapid Hemostasis, Even in Heparinized Blood

VASCADE Achieves Hemostasis Faster, Even in Heparinized Blood

In Vitro testing demonstrated VASCADE collagen decreases clotting time in both heparinized and non-heparinized blood when compared against control.⁵

¹RESPECT Trial: Hermiller JB, et.al. A Prospective, Randomized, Pivotal Trial of a Novel Extravascular Collagen-Based Closure Device Compared to Manual Compression in Diagnostic and Interventional Patients Journal of Invasive Cardiology 2015;27(3):129-136. ⁵Porcine blood was heparinized to 0.42 IU of Heparin/1ml of blood. Data on file.