Image: The Vascade Vascular Closure System (VCS) (Photo courtesy of Cardiva Medical).
An innovative extravascular device facilitates entry site closure in patients undergoing percutaneous procedures through the femoral artery.
The Vascade Vascular Closure System (VCS) utilizes a unique delivery system based on a proprietary collapsible disc technology made of a biconvex low-profile nitinol, which provides temporary hemostasis during the procedure, eliminating the need for an intravascular component. Secure and rapid hemostasis is achieved by the deployment of a thrombogenic, resorbable collagen hemostatic coating patch, which accelerates coagulation at the arteriotomy site in the femoral artery by expanding approximately 13 times in volume, thus ensuring that the residual tissue tract is sufficiently filled and provides mechanical hemostasis.
The VCS is indicated for femoral arterial access site closure while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures using a procedural sheath. The simple-to-use technique avoids the need for sheath exchange or added complexity, enabling deployment in as little as 30 seconds. The Vascade VCS is a product of Cardiva Medical (Sunnyvale, CA, USA), and has been approved by the US Food and Drug Administration (FDA).
“Vascade is a new generation of extravascular closure technology that offers significant advantages over conventional closure devices and manual compression,” said Frank Zidar, MD, of the Heart Hospital of Austin (TX, USA). “I am excited to be able to provide Vascade to my patients and to integrate it into my practice.”
The safety and effectiveness of Vascade VCS was evaluated in 420 patients across 21 clinical sites (up to 30 days post diagnostic or interventional procedures), that showed that the system is more effective than manual compression for mean time for hemostasis (TTH) and mean time to ambulation (TTA), and with fewer complications.