Boston, Massachusetts, August 3, 2026
Haemonetics Corporation has announced the publication of a major real-world clinical study providing additional evidence supporting the safety and effectiveness of the VASCADE MVP® XL Venous Vascular Closure System in electrophysiology procedures involving large-bore sheaths. The retrospective cohort study, conducted at Emory University, represents the largest reported patient cohort evaluating the VASCADE MVP XL system to date, including 1,623 patients undergoing electrophysiology procedures such as pulsed field ablation (PFA) for atrial fibrillation (AF), left atrial appendage closure (LAAC) and other concomitant interventions. The findings demonstrated rapid hemostasis, a 92.5% same-day discharge rate, and a low vascular complication rate of 1.2%, reinforcing the system’s growing role in improving procedural efficiency and patient outcomes. The publication further strengthens the clinical evidence supporting Haemonetics’ vascular closure technology following the expanded U.S. FDA labeling approval granted earlier this year for use with 10–14F inner diameter and up to 17F outer diameter procedural sheaths.
Large Real-World Study Demonstrates Strong Clinical Outcomes
The newly published study evaluated the performance of the VASCADE MVP XL system across a broad population of patients treated during large-bore venous access electrophysiology procedures. Researchers analyzed outcomes from 1,623 consecutive patients, making it the largest real-world evaluation of the technology reported to date. Clinical findings showed that the device achieved a median hemostasis time of just two minutes, allowing physicians to rapidly secure vascular access sites following complex cardiac procedures. Additionally, patients experienced a median discharge time of 3.5 hours, with 92.5% discharged on the same day, supporting growing efforts to reduce hospital stays and improve healthcare efficiency. Importantly, the study reported an overall vascular complication rate of only 1.2%, with no surgical interventions required, highlighting the system’s favorable safety profile even in patients undergoing procedures involving larger sheath sizes. Investigators noted that the study included patients with varying clinical complexities, including individuals undergoing PFA, LAAC, and combined electrophysiology procedures, demonstrating consistent performance across diverse patient populations.
Expanded FDA Labeling Supports Broader Electrophysiology Applications
The publication builds upon the expanded FDA approval received by VASCADE MVP XL in March 2026, which broadened the device’s indication to include procedures using 10–14F inner diameter and up to 17F outer diameter sheaths. The expanded labeling allows physicians to utilize the vascular closure system following procedures performed with several leading electrophysiology technologies, including Abbott’s Volt® PFA System, Boston Scientific’s FARAPULSE®, Medtronic’s Sphere-9® catheter, and Boston Scientific’s WATCHMAN TruSteer® left atrial appendage closure system. Regulatory approval was supported by evidence from the AMBULATE EXPAND clinical trial, which demonstrated rapid hemostasis without vascular complications while enabling same-day patient discharge. According to Haemonetics, VASCADE MVP XL remains the only extravascular venous closure system clinically proven for electrophysiology procedures using sheaths up to 17F outer diameter, providing clinicians with a differentiated solution as adoption of advanced cardiac ablation technologies continues to grow worldwide.
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Clinical Evidence Reinforces Innovation in Cardiac Electrophysiology
The latest findings further strengthen Haemonetics’ position within the rapidly evolving interventional cardiology and electrophysiology market, where healthcare providers continue seeking technologies that improve procedural efficiency, patient safety and hospital resource utilization. As pulsed field ablation gains momentum for treating atrial fibrillation, reliable vascular closure systems have become increasingly important for reducing access-site complications while supporting early patient mobilization and outpatient care. The study’s investigators emphasized that the real-world evidence demonstrates the VASCADE MVP XL system’s ability to deliver consistent outcomes even among patients with higher comorbidities undergoing complex procedures. By combining robust clinical evidence with expanded regulatory approval, Haemonetics continues to strengthen its portfolio of advanced vascular closure technologies, supporting physicians in delivering safer, faster and more efficient cardiovascular procedures while improving the overall patient experience across modern electrophysiology practice.
Source: Haemonetics press release
