Haemonetics Corporation has announced US Food and Drug Administration (FDA) approval to expand the labelling for the Vascade MVP XL venous vascular closure system to include procedures using 10–14Fr inner diameter (ID) and up to 17Fr 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 (AF).
US FDA approval was supported by clinical evidence from the AMBULATE EXPAND trial, a multicentre, prospective, single-arm, pivotal trial designed to evaluate the safety and effectiveness in technologies using 17Fr maximum OD procedural sheaths.
The study enrolled 77 patients at eight US centres and demonstrated 0% major and 0% minor access site closure-related complications, and a median time to ambulation (TTA) of 2.4 hours. The study results were presented at the 2026 AF Symposium (5–7 February, Boston, USA) and published in the Journal of Cardiovascular Electrophysiology in March.
The Vascade MVP XL system features a 25Fr diameter disc and 19mg of resorbable, thrombogenic collagen and has been available in the USA for use with 10–12Fr ID and 15Fr maximum OD procedural sheaths. It is now the only extravascular venous closure system clinically proven in electrophysiology procedures using up to 17Fr OD procedural sheaths, according to Haemonetics.
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, the company also states in a press release.
“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 of 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 USA.”
