Cardiva Medical out of Sunnyvale, CA received FDA Premarket Approval (PMA) for the VASCADE Vascular Closure System, an extravascular device for speedy femoral arterial access site closure. The device is designed to induce hemostasis and close openings, without leaving anything inside the artery, created by size 5F, 6F, or 7F sheaths. It allows clinicians to re-access the site after closure and is meant to be painless to the patient. From the announcement:
Clinical data from a prospective, multi-center, randomized 420 patient trial demonstrated that the VASCADE VCS is clinically and statistically superior in both safety and efficacy compared to manual compression, the gold standard for vascular closure for patients undergoing percutaneous procedures through the femoral artery.
James Hermiller, M.D. of The Heart Center, Indianapolis, who served as Principal Investigator for the trial said, “I am extremely pleased with the outstanding clinical performance of VASCADE and with the extraordinary contributions by over 65 clinical investigators and their staff at over 20 clinical sites in the U.S and Australia who facilitated the study. With PMA approval, VASCADE will now be available in the U.S. to all physicians who need safe and effective vascular closure.”
VASCADE, an extravascular closure device, utilizes a unique delivery system based on a proprietary collapsible disc technology that provides temporary hemostasis during the procedure which eliminates the need for an intra-vascular component. Secure and rapid hemostasis is achieved with VASCADE by the deployment of a thrombogenic resorbable collagen patch at the arteriotomy of the femoral artery.
Product page: VASCADE Vascular Closure System
Press release: Cardiva Medical, Inc. Announces U.S. FDA Approval for VASCADE™ Vascular Closure System
