Haemonetics Corporation, a global medical technology company focused on delivering innovative solutions designed to improve patient outcomes, announced U.S. Food and Drug Administration (FDA) approval to expand the labelling for the VASCADE MVP XL venous vascular closure system to include procedures using 10-14F inner diameter (ID) and up to 17F outer diameter (OD) procedural sheaths. With this label expansion, the VASCADE MVP XL system is approved for larger sheaths used in market-leading technologies for pulsed field ablation (PFA) and left atrial appendage closure (LAAC) to treat atrial fibrillation.
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 of technologies using 17F maximum OD procedural sheaths, such as PFA and LAAC. The study enrolled 77 patients at eight U.S. centres and demonstrated 0 per cent major and 0 per cent 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.
"VASCADE MVP XL has become the device of choice in advanced vascular closure, delivering differentiated clinical benefits and economic advantages for healthcare providers," said Ken Crowley, Vice President and General Manager, Interventional Technologies at Haemonetics. "With label expansion approval for fast-growing PFA and LAAC technologies, we are poised to accelerate our commercial strategy and momentum, with opportunities to support a greater number and broader range of procedures at hospitals and ambulatory surgical centres across the U.S."
