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Venous vascular closure system receives FDA approval
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Cardiva Medical announced that a venous vascular closure system has received premarket approval from the FDA for use for multisite vessel closure after electrophysiology procedures.
The venous vascular closure system (Vascade MVP, Cardiva Medical) is specifically labeled for multisite venous closure for 6F to 12F inner diameter sheaths and can be used in procedures such as left atrial appendage closure and cardiac ablation, according to a press release from the company.
“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, electrophysiologist at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, said in the press 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.”
The approval was based on results from the AMBULATE pivotal trial, which was presented at this year’s American Heart Association Scientific Sessions. Researchers compared the venous vascular closure system with standard manual compression after cardiac ablation. Patients assigned the venous vascular closure system had improvements in total post-procedure time, time to ambulation and time-to-discharge eligibility. These patients also had reduced use of opioid pain medications and improved patient satisfaction, according to the press release.
“We are at the dawn of a new era now for electrophysiology procedures with this trailblazing technology,” Suneet Mittal, MD, director of electrophysiology and medical director of The Snyder Center for Comprehensive Atrial Fibrillation at The Valley Hospital in Ridgewood, New Jersey, said in the press release. “The improvements we have seen in both patient satisfaction and more efficient workflow make this one of those rare new technologies that produces benefits for all stakeholders.”
Disclosure: Cardiology Today could not confirm relevant financial disclosures at the time of publication.