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.