Cardiva Medical, Inc. is a privately held medical device company focused on transforming vascular closure for the benefit of patients, hospitals and physicians in the over 5.5 million catheter-based coronary, peripheral and electrophysiology procedures in the United States that require access site closure each year.
The Company’s VASCADE® vascular closure system has been PMA-approved by the FDA since 2013 and is indicated for vessel closure following 5-7F arterial and venous procedures. VASCADE® is the only marketed closure system to demonstrate a statistically significant reduction in access site complications compared to the existing standard of care in a prospective, randomized, controlled clinical trial called RESPECT.
The latest product in the Company’s portfolio is VASCADE® MVP Venous Vascular Closure System, the only marketed vessel closure technology designed specifically for Electrophysiology procedures – and clinically proven by Electrophysiology physicians in a multi-center, randomized, controlled clinical trial called AMBULATE. VASCADE® MVP received PMA approval in late 2018.
Cardiva has won numerous recent awards for clinical, commercial and operational excellence – including the Shingo Bronze Medallion. The Company is headquartered in Santa Clara, California.
VASCADE MVP® receives FDA approval for 6-12F Inner Diameter (ID) multi-vessel venous vascular closure
Antegrade Study results published in Vascular Disease Management in 2018
VASCADE® receives FDA approval for use in femoral veins in 2018
VASCADE VCS approved by the FDA in 2013
VASCADE VCS approved for CE Mark in Europe in 2012
CATALYST III received 510(k) clearance in 2009
CATALYST II approved for CE Mark in Europe in 2008
CATALYST II received 510(k) clearance in 2007