FDA Approves Cardiva Medical's Vascade MVP Vascular Closure System
December 18, 2018—Cardiva Medical, Inc. announced that the company has received FDA premarket approval for its Vascade MVP venous vascular closure system.
The device is indicated for percutaneous closure of femoral venous access sites while reducing time to ambulation, total postprocedure time, time to hemostasis, and time to discharge eligibility in patients who have undergone catheter-based procedures utilizing 6- to 12-F inner diameter procedural sheaths with single or multiple access sites in one or both limbs. This access site approach and size range is the standard in electrophysiology procedures such as cardiac ablation and left atrial appendage closure, noted the company,
According to Cardiva, Vascade MVP is a fully integrated, extravascular, bioabsorbable femoral access closure system that combines Cardiva's collapsible disc delivery system and a thrombogenic resorbable collagen patch in an integrated design. The simple delivery system is used to place a collagen patch on the outside of each vessel puncture site after 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 FDA 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 after cardiac ablation.
Findings from the AMBULATE trial were presented by Coprincipal Investigator Andrea Natale, MD, at the American Heart Association 2018 Scientific Sessions held November 10–12 in Chicago, Illinois. Compared to manual compression, the Vascade MVP system met all primary and key secondary endpoints. The study showed significant improvements in time to ambulation, total postprocedure time, and time to discharge eligibility, as well as improved patient satisfaction scores and reduced use of opioid pain medications.