California medical device company Cardiva Medical won FDA approval for its Vascade extravascular closure device, the company announced this week.
The premarket approval was granted based on evidence from Cardiva’s 420-patient clinical trial, which demonstrated that Vascade beat the gold standard of manual compression for vascular closure patients undergoing percutaneous procedures via the femoral artery, according to a press release.
"Cardiva is well positioned to bring this technology to the marketplace to increase patient throughput and provide a safer and more effective alternative to manual compression across the United States," president & CEO Charles Maroney said in prepared remarks.
The Vascade device features proprietary "collapsible disc technology that provides temporary hemostasis" via a thrombogenic, resorbable collagen patch delivered to the opening in the artery wall, according to a the press release.
The Vascade system won CE Mark approval for the European Union last year.