Haemonetics Receives FDA Approval to Expand Vascade MVP XL Label

April 1, 2026—Haemonetics announced that it has received FDA approval for expanded labeling of its Vascade MVP XL venous vascular closure system to include procedures using with 10- to 14-F inner diameter (ID) and up to 17-F outer diameter (OD) sheaths, according to a company press release.

The label expansion broadens the device’s use in electrophysiology procedures requiring large-bore venous access, including pulsed field ablation and left atrial appendage closure, both of which are increasingly used in the treatment of atrial fibrillation. The updated indication removes the need to downsize sheaths before closure, a step that can add procedural time.

FDA approval was supported by results from the AMBULATE EXPAND trial, a multicenter, prospective, single-arm pivotal study evaluating safety and effectiveness in procedures using up to 17-F OD sheaths. The trial enrolled 77 patients across eight United States centers and reported 0% major and 0% minor access site closure–related complications in the per-protocol population, with a median time to ambulation of 2.4 hours. Study findings were presented at AF Symposium 2026 and published in Journal of Cardiovascular Electrophysiology in March.

The Vascade MVP XL system uses a collapsible disc and resorbable collagen patch designed to promote hemostasis after venous access. The device was previously indicated for use with 10- to 12-F ID and up to 15-F OD sheaths.

Haemonetics stated that its Vascade portfolio includes devices for small-, mid-, and large-bore femoral access closure across interventional and electrophysiology procedures.