Expanded labeling includes procedures using 10-14F inner diameter (ID) and up to 17F outer diameter (OD) procedural sheaths. This grants Vascade MVP XL approval for larger sheaths used in market-leading technologies used for pulsed field ablation (PFA) and left atrial appendage closure (LAAC) to treat AFib.
Vascade MVP XL previously won FDA clearance as a mid-bore closure device in June 2024. It features a 25F diameter disc and 19 milligrams of resorbable, thrombogenic collagen. Previous U.S. availability extended to 10-12F ID and 15F maximum OD procedural sheaths.
Haemonetics says its system is now the only extravascular venous closure system clinically proven in electrophysiology procedures using up to 17F OD procedural sheaths. Using the system means physicians don’t need to downsize a procedural sheath to a smaller size for closure. This can increase procedural time.
The company supported approval with data form the AMBULATE EXPAND trial of 77 patients in the U.S. It evaluated Vascade MVP XL in PFA and LAAC, producing 0% major and 0% minor access site closure-related complications. Median time to ambulation came in 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.”
