Cardiva Medical Has Strong Showing at AHA

Cardiva Medical’s vascular closure system has met its clinical endpoints in the AMBULATE randomized pivotal trial. The Santa Clara, CA-based company’s VASCADE MVP, a vascular closure system designed specifically for multi-access venous closure following electrophysiology procedures such as arrhythmia ablation was evaluated in the study. Results from the trial were presented at American Heart Association 2018 Scientific Sessions, held in Chicago. AMBULATE enrolled 204 patients who underwent arrhythmia ablation procedures by 28 physicians at 13 sites across the US. The treatment group had all sites closed with the VASCADE MVP System, while the control group had all sites closed using manual compression, which is the current standard of care. “The patients all have venous access sites in the groin,” John Russell, president and CEO of Cardiva, told MD+DI. “They all use larger sheath sizes than the standard closure procedures. Because most of the patients [have] atrial fibrillation they are all on uninterrupted anticoagulation drugs.” He added, “For these procedures the standard of care is still manual compression to close between three and five puncture sites. After that the patient has to be confined to bed rest for about six to eight hours. No one has designed a closure device that has been designed specifically for this use – much less...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Cardiovascular Source Type: news