News | Vascular Closure Devices | February 21, 2018

Cardiva Medical Announces $41 Million for AMBULATE Vascular Closure Device Trial

New vascular closure device for multi-access mid-bore vein procedures, specifically cardiac ablation, aims to reduce time to ambulation and improve the patient experience

Cardiva Medical Announces $41 Million for AMBULATE Vascular Closure Device Trial

February 21, 2018 – Vascular closure device provider Cardiva Medical announced that the company has closed on $11 million in additional financing – bringing total equity and debt financing in the current round to $41 million. The additional financing exceeds previous commitments for this round and includes returning equity and debt investors – including PTV Healthcare Capital, Canepa Healthcare, and affiliates of Luther King Capital Management.

Funds will be used to continue U.S. commercial expansion of the Vascade Vascular Closure System and to fund the AMBULATE clinical trial, an investigational device exemption (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 transcatheter procedures.

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 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 Andrea Natale, M.D., executive medical director, Texas Cardiac Arrhythmia Institute; Mintu Turakhia, M.D., MAS, associate professor, Stanford University School of Medicine; and Steve Compton, M.D., of the Alaska Heart and Vascular Institute.

There are over 6 million interventional arterial procedures a year in the United States alone, and bleeding at the access site remains the No. 1 source of complications for these patients. The Vascade Vascular Closure System is the only closure system, according to Cardiva, 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 U.S. Food and Drug Administration (FDA), and has received CE Mark.

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