A clinical study by Cardiva Medical evaluating its bioabsorbable vascular closure system for electrophysiology procedures met all of its primary and secondary endpoints compared to manual compression, the current standard of care.
The company’ s Vascade MVP system—designed for multi-access venous closures, following procedures such as cardiac arrhythmia ablation—demonstrated shorter bed rest times and decreases in the subsequent use of opioid pain medications. The system was able to get patients on their feet nearly four hours faster, on average.
The study, which enrolled 204 arrhythmia ablation patients with three or four mid-bore femoral venous access sites, also reduced total post-procedure times, allowing patients to be discharged faster.
The Santa Clara, California-based Cardiva described the study as the first randomized pivotal trial of vessel closure conducted exclusively by electrophysiology physicians. The results were presented at the American Heart Association’s Scientific Sessions conference.
The Vascade MVP system consists of a collapsible mesh disc that places a resorbable collagen patch against the inside of the vessel wall to seal the hole and halt the bleeding. The disc and the patch leave no permanent components behind and allow additional access to the vessel if needed. The MVP system has been submitted for premarket approval and is currently under review by the FDA.
The larger Vascade closure system and collapsible disc technology was first approved by the FDA in 2013. Last year, Cardiva raised $30 million in equity to bankroll its commercial expansions.
Cardiva is also conducting studies examining hospital workflows and economics following ablation procedures using the system, as well as the longer-term safety of Vascade MVP and earlier hospital discharges.