The FDA has granted premarket approval to Cardiva Medical’s vascular closure system for use during electrophysiology procedures such as cardiac ablation and left atrial appendage closure, the company announced Dec. 18.
According to a press release, the Vascade MVP system is the first vascular closure system labeled specifically for multisite venous closure for 6-12 French inner diameter sheaths.
To use the percutaneous product, a collapsible mesh disc is placed inside the vessel wall to temporarily stop the bleeding. A collagen patch is then released into the tissue tract, allowing the disc to be removed while the expanded collagen patch serves as a seal. The collagen eventually absorbs into the body, leaving the vessel open if additional procedures are necessary.
Approval of the system was based on the AMBULATE pivotal trial, which included 204 patients randomized to vascular closure with the Vascade MVP or standard manual compression. Those treated with Cardiva Medical’s device were able to ambulate a median of 3.9 hours earlier (2.2 hours versus 6.1 hours) and were deemed eligible for discharge a mean 3.4 hours earlier. They were also significantly more satisfied with the duration of bed rest and required opioid-class pain medications only 15 percent of the time, compared to 36 percent of the time in the manual compression arm.
“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,” Amin Al-Ahmad, MD, an electrophysiologist at Texas Cardiac Arrhythmia Institute, said in the release. “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.”
John Russell, CEO of Santa Clara, California-based Cardiva Medical, said the company has already begun shipping Vascade MVP systems to select centers in the U.S.