December 18, 2018
VASCADE MVP Venous Vascular Closure System (VASCADE MVP) is the first and only vascular closure system designed and labeled specifically for multi-site venous closure – for 6-12 French inner diameter sheaths. This access site approach and size range is the standard in electrophysiology procedures such as cardiac ablation and left atrial appendage closure. Today Cardiva Medical announces it has received U.S. Food and Drug Administration (FDA) approval.
VASCADE MVP uses a simple and proprietary delivery system to place a collagen patch on the outside of each vessel puncture site following completion of the procedure. Nothing is left behind inside the vessel, and the collagen outside the vessel wall is resorbed in a short period of time enabling reaccess for future procedures.
The approval is based on results of the AMBULATE Pivotal Trial, a 204-patient, 13-site randomized, controlled study of the VASCADE MVP System compared to standard manual compression following cardiac ablation. The study showed significant improvements in time to ambulation, total post-procedure time and time-to-discharge eligibility, as well as improved patient satisfaction scores and reduced use of opioid pain medications. Results of the trial were presented at the 2018 AHA Scientific Sessions by Andrea Natale, M.D., co-principal investigator and executive medical director, Texas Cardiac Arrhythmia Institute in Austin, Texas.
“We are at the dawn of a new era now for electrophysiology procedures with this trailblazing technology,” said Suneet Mittal, M.D., director of electrophysiology and medical director of The Snyder Center for Comprehensive Atrial Fibrillation at The Valley Hospital in Ridgewood, New Jersey. “The improvements we have seen in both patient satisfaction and more efficient hospital workflow make this one of those rare new technologies that produces benefits for all stakeholders.”
“With the VASCADE MVP device, we have been able to get patients safely on their feet hours earlier than previously possible after an ablation for atrial fibrillation or a left atrial appendage closure procedure,” said Amin Al-Ahmad, M.D., electrophysiologist at Texas Cardiac Arrhythmia Institute. “In our practice the new Cardiva workflow has freed up staff and beds – and patient satisfaction has skyrocketed with less time spent immobilized on their backs. This new workflow may also make it possible to send more patients home the same day as their procedure.”
“Approval of the VASCADE MVP System marks the culmination of a multi-year effort by Cardiva to pioneer the first dedicated vessel closure solution for electrophysiology procedures such as cardiac ablation and left atrial appendage closure,” said John Russell, CEO of Cardiva Medical. “We are proud to have partnered with leading EP physicians in the United States to address this unmet need – and enable patients to get back on their feet sooner and improve the workflow for these highly successful procedures. This approval – our second PMA approved product – is an exciting milestone for our team, and shipments to leading centers in the United States have already begun.”