Cardiva touts results from pivotal Vascade MVP vascular closure device trial

Cardiva Medical today released results from the pivotal study of its Vascade MVP vascular closure device intended for multi-access venous closure following electrophysiology procedures, touting that the trial met its primary and secondary endpoints. The results from the AMBULATE trial were presented today at the American Heart Association’s annual Scientific Sessions by Texas Cardiac Arrhythmia Institute exec medical director Dr. Andrea Natale. The Vascade system is composed of a thrombogenic bioabsorbable collagen patch and a collapsible mesh disc, the Santa Clara, Calif.-based company said. The device functions by placing a collapsible mesh disc against the inner vessel wall to stop bleeding followed by a collagen patch and the removal of the mesh disc, the company said. The collagen patch is designed to expand, seal and stop bleeding and is later absorbed by the body. In the trial, investigators examined data from 204 patients who underwent arrhythmia ablation procedures. Each patient in the trial had three or four mid-bore femoral venous access sites and were randomized to either receive treatment with the Vascade MVP system or using manual compression, which is the current standard of care. The study met its primary and secondary endpoints of time to ambulation, reductions in total procedure time, reduced time to discharge eligibility, improved patient satisfaction and reduction in the use of opioid pain medications, Cardiva said. Patients treated with the Vascad...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Vascular Cardiva Medical Inc. Source Type: news