FDA approval was supported by clinical evidence from the AMBULATE EXPAND trial, a multicenter, prospective, single-arm, pivotal trial designed to evaluate the safety and effectiveness in technologies using 17F maximum OD procedural sheaths, such as PFA and LAAC. The study enrolled 77 patients at eight U.S. centers and demonstrated 0% major and 0% minor access site closure-related complications and a median time to ambulation (TTA) of 2.4 hours1. The study results were presented at the AF Symposium 2026 in Boston in February and published in the Journal of Cardiovascular Electrophysiology in March.
The VASCADE MVP XL system features a 25F diameter disc and 19 milligrams of resorbable, thrombogenic collagen and has been available in the U.S. for use with 10-12F ID and 15F maximum OD procedural sheaths. It is now the only extravascular venous closure system clinically proven in electrophysiology procedures using up to 17F OD procedural sheaths. With the VASCADE MVP XL system, there is no need for physicians to downsize a procedural sheath to a smaller size for closure, which can increase procedural time.