New Study Strengthens Evidence Supporting VASCADE MVP® XL System for Large-Bore Electrophysiology Procedures
Haemonetics Corporation, a global medical technology company specializing in innovative solutions designed to improve patient care and clinical outcomes, has announced the publication of a new clinical study providing additional evidence supporting the safety and effectiveness of its VASCADE MVP® XL Venous Vascular Closure System. The study, which evaluated the device in real-world clinical practice, represents the largest patient cohort reported to date using the VASCADE MVP XL system for large-bore venous access closure following electrophysiology (EP) procedures.
The findings reinforce the growing body of evidence demonstrating that the VASCADE MVP XL system can provide rapid vascular closure, enable high rates of same-day patient discharge, and maintain a low incidence of vascular complications following complex cardiac procedures requiring large-bore venous sheaths.
As electrophysiology continues to evolve with the introduction of advanced technologies such as pulsed field ablation (PFA) and left atrial appendage closure (LAAC), effective vascular closure has become increasingly important for improving patient recovery, reducing hospital stays, and supporting efficient workflow within cardiac care programs.
Largest Real-World Evaluation to Date
The newly published research was conducted at Emory University and funded through a research grant from Haemonetics.
Researchers performed a single-center retrospective cohort study involving 1,623 patients who underwent electrophysiology procedures requiring large-bore venous access and subsequently received vascular closure using the VASCADE MVP XL system.
According to the investigators, this represents the largest real-world patient population studied for the device to date, providing valuable evidence regarding its clinical performance across a broad range of patient types and procedural complexities.
Unlike highly controlled clinical trials that often involve carefully selected participants, retrospective real-world studies evaluate outcomes in routine clinical practice, offering insight into how medical technologies perform across diverse patient populations.
Growing Need for Reliable Vascular Closure
Electrophysiology procedures have become increasingly sophisticated over the past decade.
Modern treatments for complex cardiac rhythm disorders frequently require the insertion of larger vascular sheaths to accommodate advanced mapping systems, ablation catheters, and structural heart devices.
After these procedures are completed, physicians must safely close the venous access site to prevent bleeding and vascular complications while enabling patients to recover quickly.
Traditional approaches often rely on prolonged manual compression, which can increase recovery time and delay patient discharge.
Vascular closure devices like the VASCADE MVP XL system are designed to simplify this process by providing faster hemostasis and improving overall patient comfort.
Procedures Included in the Study
Patients included in the study underwent a variety of large-bore electrophysiology procedures.
These included:
- Pulsed Field Ablation (PFA) for atrial fibrillation
- Left Atrial Appendage Closure (LAAC)
- Combined electrophysiology procedures
- Concomitant structural heart interventions
All procedures involved large-bore venous access using sheaths up to 17 French (17F) outer diameter, reflecting the growing adoption of larger delivery systems required by next-generation cardiovascular technologies.
The VASCADE MVP XL system was used to achieve vascular closure following completion of these interventions.
Rapid Hemostasis Demonstrated
One of the study’s most significant findings involved the speed with which bleeding was controlled after sheath removal.
Researchers reported a median time to hemostasis of only two minutes.
Rapid hemostasis offers several important clinical advantages.
These include:
- Reduced bleeding risk
- Earlier patient mobilization
- Improved patient comfort
- Greater procedural efficiency
- Reduced nursing workload
- Shorter recovery periods
Achieving reliable vascular closure quickly has become particularly valuable as healthcare providers increasingly seek to perform more procedures on an outpatient basis.
High Same-Day Discharge Rates
Another major outcome reported in the study was the exceptionally high rate of same-day discharge.
Researchers found that 92.5% of patients were discharged on the same day as their electrophysiology procedure.
Among these patients, the median time from procedure completion to discharge was approximately 3.5 hours.
Same-day discharge has become an important objective for many cardiovascular programs because it offers benefits for both patients and healthcare systems.
Patients generally prefer recovering at home whenever medically appropriate, while hospitals benefit from:
- Increased procedural capacity
- Improved resource utilization
- Reduced inpatient costs
- Greater operational efficiency
- Enhanced patient satisfaction
The ability to discharge patients safely only a few hours after complex electrophysiology procedures reflects significant advances in procedural techniques, vascular closure technology, and post-procedure care protocols.
Strong Safety Profile
Safety remained another key focus of the study.
Investigators reported an overall vascular complication rate of just 1.2%, demonstrating favorable clinical performance across a large and diverse patient population.
Importantly, no patients required surgical intervention to manage vascular complications.
Avoiding surgical repair represents a significant clinical benefit, as it minimizes patient morbidity while reducing healthcare utilization and recovery time.
The low complication rate further supports the use of the VASCADE MVP XL system in increasingly complex electrophysiology procedures involving larger venous access sites.
Supporting Complex Cardiac Procedures
Electrophysiology continues to experience rapid innovation, particularly in the treatment of atrial fibrillation and structural heart disease.
Many newer technologies require larger delivery systems than those used historically.
These procedures include:
Pulsed Field Ablation
Pulsed Field Ablation has emerged as an important advancement in treating atrial fibrillation.
Unlike conventional thermal ablation techniques that rely on heat or freezing, PFA uses precisely controlled electrical pulses to selectively destroy abnormal heart tissue while minimizing injury to surrounding structures.
The technique has generated significant interest because of its potential to improve procedural safety and efficiency.
Left Atrial Appendage Closure
Left atrial appendage closure is increasingly performed in patients with atrial fibrillation who require alternatives to long-term anticoagulation therapy.
Devices used during these procedures often require large delivery sheaths, making reliable vascular closure essential for minimizing bleeding complications.
Combined Procedures
Many patients now undergo multiple cardiac interventions during a single procedure.
Managing vascular access effectively becomes even more important when multiple large sheaths are used during these complex interventions.
Clinical Perspective
Ken Crowley, Vice President and General Manager of Interventional Technologies at Haemonetics, said the study further demonstrates the consistent performance of the VASCADE MVP XL system across a large and diverse patient population.
He emphasized that physicians performing electrophysiology procedures increasingly seek vascular closure technologies capable of improving both clinical outcomes and patient experiences.
According to Crowley, the system provides electrophysiology teams with a reliable solution that supports rapid hemostasis while enabling efficient same-day discharge for patients undergoing PFA, LAAC, and other complex procedures.
As cardiac electrophysiology continues evolving, technologies that streamline post-procedure recovery are expected to become increasingly valuable.
Independent Clinical Assessment
The study’s corresponding author, David B. De Lurgio, M.D., serves as Medical Director of Electrophysiology at Emory Saint Joseph’s Hospital and is a professor of medicine at the Emory University School of Medicine.
Dr. De Lurgio highlighted the importance of achieving consistent same-day discharge even among patients treated with larger vascular sheaths than those historically used with vascular closure devices.
He noted that evaluating more than 1,600 patients provided meaningful real-world evidence across a wide spectrum of procedures and patient characteristics.
The cohort included patients with:
- Multiple cardiovascular conditions
- Higher medical complexity
- Structural heart disease
- Left atrial appendage closure procedures
- Combined electrophysiology interventions
According to the investigators, these findings suggest that the VASCADE MVP XL system performs consistently even in patients presenting with greater clinical complexity.
FDA Expanded Labeling Earlier This Year
The study follows an important regulatory milestone achieved earlier in 2026.
In March 2026, the U.S. Food and Drug Administration approved expanded labeling for the VASCADE MVP XL Venous Vascular Closure System.
The updated indication now includes vascular closure following procedures using:
- 10–14 French inner diameter (ID)
- Up to 17 French outer diameter (OD) procedural sheaths
This expanded labeling reflects the growing use of larger access systems required by modern electrophysiology technologies.
Compatibility with Leading Electrophysiology Platforms
The expanded FDA indication supports use of the VASCADE MVP XL system following procedures utilizing several leading cardiac technologies.
These include:
- Abbott’s Volt® Pulsed Field Ablation System
- Boston Scientific’s FARAPULSE® platform
- Medtronic’s Sphere-9® catheter
- Boston Scientific’s WATCHMAN TruSteer® left atrial appendage closure system
Compatibility with these widely adopted technologies allows hospitals and electrophysiology programs to standardize vascular closure across multiple procedure types.
Earlier Clinical Evidence
The FDA’s expanded approval was supported by findings from the AMBULATE EXPAND clinical trial.
That study demonstrated that the VASCADE MVP XL system:
- Achieved rapid hemostasis
- Produced no vascular complications
- Supported safe same-day discharge
The newly published Emory study complements those earlier clinical findings by demonstrating similar outcomes within routine clinical practice involving substantially larger patient numbers.
Together, the clinical trial and real-world evidence provide a comprehensive understanding of the device’s performance.
Unique Position in the Market
According to Haemonetics, the VASCADE MVP XL system currently remains the only extravascular venous closure system with clinical evidence supporting its use in electrophysiology procedures utilizing procedural sheaths up to 17F outer diameter.
Extravascular closure differs from certain traditional closure methods because the device achieves hemostasis without leaving permanent components inside the blood vessel.
This design may offer procedural advantages while maintaining vascular integrity.
As demand grows for minimally invasive cardiovascular procedures requiring increasingly larger vascular access, technologies capable of safely managing these access sites are becoming increasingly important.
Advancing Patient-Centered Electrophysiology Care
The evolution of electrophysiology is increasingly focused not only on procedural success but also on improving the overall patient experience.
Rapid recovery protocols, shorter hospital stays, minimally invasive techniques, and same-day discharge programs are becoming standard goals for many leading cardiovascular centers.
Vascular closure technologies that support these objectives contribute to:
- Faster recovery
- Improved patient satisfaction
- Reduced healthcare costs
- Greater procedural efficiency
- Better utilization of hospital resources
The newly published evidence suggests the VASCADE MVP XL system aligns well with these evolving priorities.
The publication of this large real-world study represents another important milestone for Haemonetics and its growing portfolio of cardiovascular technologies. By demonstrating rapid hemostasis, high same-day discharge rates, and a low incidence of vascular complications across more than 1,600 patients undergoing complex electrophysiology procedures, the research provides strong additional evidence supporting the safety and effectiveness of the VASCADE MVP XL Venous Vascular Closure System.
Combined with the recent FDA expanded labeling and previous findings from the AMBULATE EXPAND trial, the latest study further strengthens confidence in the device’s role within modern electrophysiology practice. As hospitals continue expanding the use of pulsed field ablation, left atrial appendage closure, and other advanced cardiac procedures requiring large-bore venous access, technologies like the VASCADE MVP XL system are expected to play an increasingly important role in enabling faster recovery, improving clinical outcomes, and enhancing the overall patient care experience.
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