Cardiva Medical won FDA approval for its VASCADE MVP Venous Vascular Closure System, a device used for multi-site venous closure post cardiac ablation, left atrial appendage closure, and other electrophysiology procedures. It’s available in sheaths from 6 to 12 French inner diameter
The device is used to deliver a collagen patch onto the exterior of each vessel puncture site following the main procedure. Nothing remains within the vessel and the patch eventually breaks up and is resorbed into the body. The same site can be used for repeat access if future procedures are necessary.
“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,” in a statement 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.”
Here’s some details about what led to the FDA approval:
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.