Haemonetics’ VASCADE MVP® XL Demonstrates Strong Safety and Efficacy in Large-Bore Venous Closure, New Study Finds
Haemonetics Corporation a global leader in medical technology solutions aimed at improving patient outcomes, has announced the publication of new clinical research evaluating its VASCADE MVP® XL vascular closure system. The study compares the performance of VASCADE MVP XL with the earlier VASCADE MVP system in large-bore venous access closure procedures, a critical component of many advanced cardiovascular interventions.
The study, titled VASCADE MVP-XL Versus VASCADE MVP for Large-Bore Venous Access-Site Closure in Electrophysiology Procedures: A Single-Center Experience on Efficacy and Complications,was recently published in the Journal of Cardiovascular Electrophysiology. It provides important insights into the safety, effectiveness, and clinical outcomes associated with these devices in real-world settings.
Study Design and Patient Population
This retrospective, non-randomized, observational cohort study was conducted at a single center and included 574 consecutive patients. All participants underwent complex cardiovascular procedures such as catheter ablation for atrial arrhythmias or left atrial appendage closure (LAAC). These procedures often require large-bore venous access, which presents unique challenges for safe and efficient closure.
Notably, some procedures involved the use of the original VASCADE MVP system outside its approved indication range (6–12F inner diameter sheaths), providing a broader comparison of device performance under varied clinical conditions.
Key Findings: Superior Performance of VASCADE MVP XL
The findings of the study highlight the strong clinical performance of VASCADE MVP XL in large-bore venous closure:
- Higher procedural success rates compared to the earlier-generation device
- Consistent safety profile across a diverse patient population
- Efficient hemostasis (rapid bleeding control)
- Zero reported bleeding complications, a significant outcome in high-risk procedures
These results underscore the system’s ability to address the growing demands of modern electrophysiology procedures, where larger sheath sizes are increasingly common.
Regulatory Milestone: Expanded FDA Approval
In March 2026, the U.S. Food and Drug Administration granted expanded labeling approval for the VASCADE MVP XL system. The updated indication allows its use with:
- 10–14F inner diameter (ID) sheaths
- Up to 17F outer diameter (OD) sheaths
This expansion significantly broadens the device’s applicability, particularly in advanced procedures involving large-bore access.
Compatibility with Next-Generation Technologies
With this expanded approval, VASCADE MVP XL is now compatible with leading cardiovascular technologies, including:
- FARAPULSE by Boston Scientific for treating atrial fibrillation
- WATCHMAN TruSteer for stroke risk reduction
Importantly, VASCADE MVP XL is currently the only extravascular venous closure system clinically validated in electrophysiology procedures using sheaths up to 17F OD.
Supporting Clinical Evidence: AMBULATE EXPAND Trial
The FDA’s decision was supported by data from the AMBULATE EXPAND trial, a multicenter, prospective, single-arm pivotal study designed to assess safety and effectiveness in procedures using large-bore sheaths.
Results from this trial, also published in the Journal of Cardiovascular Electrophysiology in March 2026, reinforced the device’s reliability and clinical value in complex interventions.
Additional Insights from Imaging Sub-Study
Further supporting evidence comes from a prospective ultrasound sub-study involving 31 patients. Published in Heart Rhythm O2, this research provided an imaging-based evaluation of vascular closure sites following device deployment.
Key observations included:
- Encouraging early vascular healing
- Positive outcomes in fully anticoagulated, high-risk patients
- Improved understanding of post-procedural vessel recovery
These findings add an important dimension to the clinical profile of VASCADE MVP XL, particularly in patients with elevated bleeding risk.
Presentation at Heart Rhythm 2026
Additional data on VASCADE MVP XL will be presented at the Heart Rhythm Society’s Heart Rhythm 2026 conference in Chicago. The research will be featured during a Haemonetics-sponsored Rhythm Theater session titled:
Efficient Workflows for AF Ablation: New Technologies and Sites of Service”
Scheduled for April 25, 2026, from 10:30 a.m. CT
Leadership Perspective
Dr. Jan Hartmann, Senior Vice President and Chief Medical Officer at Haemonetics, emphasized the importance of this advancement:
The expanded indication for the VASCADE MVP® XL system supports the rapidly evolving electrophysiology landscape, including the adoption of next-generation pulsed field ablation and left atrial appendage closure technologies. By enabling reliable venous closure in large-bore procedures, the system helps clinicians deliver safe and effective care across both hospital and outpatient settings.”
Addressing Evolving Clinical Needs
As electrophysiology continues to advance, there is a growing shift toward:
- Minimally invasive procedures
- Larger device platforms
- Outpatient and ambulatory care settings
- Greater emphasis on efficiency and cost-effectiveness
VASCADE MVP XL is positioned to meet these demands by simplifying closure workflows while maintaining high safety standards.
The newly published study reinforces VASCADE MVP XL’s role as a next-generation solution for large-bore venous access closure. With strong clinical outcomes, expanded regulatory approval, and compatibility with cutting-edge cardiovascular technologies, the system represents a meaningful step forward in improving procedural safety and efficiency.
As healthcare systems increasingly prioritize value-based care and streamlined workflows, innovations like VASCADE MVP XL are expected to play a central role in shaping the future of interventional cardiology and electrophysiology.
About Haemonetics
Haemonetics is a global medical technology company dedicated to improving the quality, effectiveness and efficiency of health care. Our innovative solutions addressing critical medical needs include a suite of hospital technologies designed to advance standards of care and help enhance outcomes for patients; end-to-end plasma collection technologies to optimize operations for plasma centers; and products to enable blood centers to collect in-demand blood components
Haemonetics Corporation is a global medical technology company focused on enhancing the quality, efficiency, and effectiveness of healthcare delivery. The company develops innovative solutions that address critical medical needs across multiple care settings. Its portfolio includes advanced hospital technologies that support improved clinical standards and patient outcomes, comprehensive plasma collection systems that streamline and optimize operations for plasma centers, and specialized products that enable blood centers to efficiently collect high-demand blood components.
