According to Cardiva Medical, the funds will be used to continue U.S. commercial expansion of the VASCADE® Vascular Closure System and to fund the AMBULATE® clinical trial, an IDE study of Cardiva’s investigational closure system for mid-bore veins (defined as 6-12 French inner diameter access sheaths) used in cardiac ablation and other procedures.
Regarding this investment, John Russell, Cardiva’s president and CEO said, “This additional investment reflects enthusiasm from our investors for the continued high rate of sales growth of VASCADE, as well as for the exciting potential of our mid-bore vein closure program.” He adds, “With the AMBULATE Trial, we are fortunate to have a world-class group of investigators engaged in this first-of-its-kind study.”
The AMBULATE Trial: Cardiac ablation procedures are performed by specialized electrophysiologists with the goal of relieving symptoms and reducing the risk of stroke for patients with atrial fibrillation, a rhythm abnormality affecting up to 6.1 million Americans. Upon completion of these procedures, multiple access sites remain from the catheters inserted via the femoral veins in the groin. Today these sites are closed by application of manual compression and the patient is confined to bed for up to six hours prior to ambulation to protect the vascular puncture sites.
The AMBULATE Trial is a prospective, multi-center, randomized, controlled study enrolling 204 patients at leading sites across the United States. Patients are randomized to vessel closure with the Cardiva Medical system versus standard manual compression. The goal of the AMBULATE Trial is to significantly reduce the time to ambulation for patients following these complex electrophysiology procedures.
Principal investigators include Dr. Andrea Natale, executive medical director, Texas Cardiac Arrhythmia Institute; Dr. Mintu Turakhia, Associate Professor, Stanford University School of Medicine; and Dr. Steve Compton, of the Alaska Heart and Vascular Institute.
FDA Approved VASCADE Vascular Closure System and RESPECT Study: There are over six million interventional arterial procedures a year in the United States alone, and bleeding at the access site remains the number one source of complications for these patients. The VASCADE Vascular Closure System is the only closure system to demonstrate a statistically significant reduction in access site complications in a prospective, randomized controlled clinical trial called RESPECT. The RESPECT study included 420 patients at 20 U.S. centers, comparing VASCADE to manual compression for femoral arterial closure. VASCADE is commercially available in the United States, where it has been approved by the FDA, and has received CE Mark.