Haemonetics Receives FDA Approval for Expanded VASCADE MVP XL Labeling to Support Advanced Atrial Fibrillation Procedures
核心洞察
Haemonetics Corporation received FDA approval to expand labeling for the VASCADE MVP XL (搜索) venous vascular closure system to include procedures using larger 10-14F inner diameter and up to 17F outer diameter procedural sheaths.
The approval enables use of the device with market-leading pulsed field ablation (搜索) and left atrial appendage closure (搜索) technologies for treating atrial fibrillation (搜索) patients.
Clinical evidence from the AMBULATE EXPAND trial demonstrated 0% major and minor access site closure-related complications with a median time to ambulation of 2.4 hours in 77 patients.
Haemonetics Corporation announced U.S. Food and Drug Administration approval to expand the labeling for the VASCADE MVP XL (搜索) venous vascular closure system to include procedures using 10-14F inner diameter and up to 17F outer diameter procedural sheaths. This label expansion enables the system's use with larger sheaths required for market-leading pulsed field ablation (搜索) and left atrial appendage closure (搜索) technologies to treat atrial fibrillation (搜索).
Clinical Evidence Supporting Approval
FDA approval was supported by clinical evidence from the AMBULATE EXPAND trial, a multicenter, prospective, single-arm, pivotal trial designed to evaluate safety and effectiveness in technologies using 17F maximum outer diameter procedural sheaths, such as pulsed field ablation (搜索) and left atrial appendage closure (搜索). The study enrolled 77 patients at eight U.S. centers and demonstrated 0% major and 0% minor access site closure-related complications and a median time to ambulation of 2.4 hours.
The study results were presented at the AF Symposium 2026 in Boston in February and published in the Journal of Cardiovascular Electrophysiology in March.
Device Specifications and Clinical Advantages
The VASCADE MVP XL (搜索) system features a 25F diameter disc and 19 milligrams of resorbable, thrombogenic collagen and has been available in the U.S. for use with 10-12F inner diameter and 15F maximum outer diameter procedural sheaths. With this approval, it becomes the only extravascular venous closure system clinically proven in electrophysiology procedures using up to 17F outer diameter procedural sheaths.
The expanded labeling eliminates the need for physicians to downsize a procedural sheath to a smaller size for closure, which can increase procedural time. This capability is particularly significant for advanced electrophysiology procedures that require larger access sheaths.
Commercial Impact and Market Position
"VASCADE MVP XL (搜索) 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, 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 centers across the U.S."
VASCADE Portfolio Overview
Haemonetics' full portfolio of VASCADE vascular closure systems features an innovative collapsible disc technology and a proprietary resorbable collagen patch designed to promote rapid hemostasis for interventional and electrophysiology procedures. The portfolio includes the VASCADE system for "small-bore" femoral arterial and venous closure with standard 5-7F inner diameter procedural sheaths, and the VASCADE MVP system for "mid-bore" multi-access femoral venous closure with 6-12F inner diameter procedural sheaths.
The systems are designed to help clinicians reduce the risk of complications, improve patient satisfaction, and enable same day discharge for various cardiovascular procedures.