The FDA has granted Cardiva Medical's premarket approval for the Vascade vascular closure system (VCS).

The approval is based on clinical data from a prospective, multicenter, randomized 420-patient trial assessing the Vascade VCS as clinically and statistically superior in both safety and efficacy compared with manual compression, the gold standard for vascular closure for patients undergoing percutaneous procedures through the femoral artery.

Vascade, an extravascular closure device, utilizes a delivery system based on a collapsible disc technology that provides temporary hemostasis during the procedure. Hemostasis is achieved with Vascade by the deployment of a thrombogenic resorbable collagen patch at the arteriotomy of the femoral artery, according to the Sunnyvale, Calif.-based company.