Haemonetics has secured an expanded regulatory milestone in the U.S., with the company confirming that the FDA has approved broader labeling for its Vascade MVP XL system. The updated approval extends the device’s applicability to procedures involving 10-14F inner diameter (ID) and up to 17F outer diameter (OD) procedural sheaths. This development enables the system to be used alongside larger sheath sizes associated with pulsed field ablation (PFA) and left atrial appendage closure (LAAC) procedures performed to treat AFib. With this step, the vascular closure system gains relevance in two rapidly advancing interventional segments.
The Vascade MVP XL system had earlier received FDA clearance in June 2024 as a mid-bore closure device. It incorporates a 25F diameter disc along with 19 milligrams of resorbable, thrombogenic collagen. Prior to this expanded indication, its U.S. usage covered procedural sheaths ranging from 10-12F ID and up to a maximum of 15F OD. The latest approval broadens that scope, aligning the vascular closure system with evolving procedural demands in electrophysiology.
According to Haemonetics, the system is currently the only extravascular venous closure system clinically proven for electrophysiology procedures utilizing up to 17F OD procedural sheaths. The design removes the need for physicians to downsize procedural sheaths during closure, a step that can otherwise extend procedural duration. By maintaining compatibility with larger sheath sizes, the system supports workflow efficiency during complex interventions.
Clinical validation supporting the approval comes from the AMBULATE EXPAND trial, which involved 77 patients in the U.S. The study assessed the system’s performance in PFA and LAAC procedures, reporting 0% major and 0% minor access site closure-related complications. Additionally, the median time to ambulation was recorded at 2.4 hours.
Ken Crowley, VP and GM, Interventional Technologies at Haemonetics, said:
“Vascade MVP XL has become the device of choice in advanced vascular closure, delivering differentiated clinical benefits and economic advantages for healthcare providers. 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 centers across the U.S.”
