BOSTON, April 24, 2026

Haemonetics Corporation has announced compelling new clinical data demonstrating the safety, efficacy, and superior performance of its VASCADE MVP® XL vascular closure system in large-bore venous access procedures. The findings, published in the Journal of Cardiovascular Electrophysiology, highlight the device’s ability to deliver reliable hemostasis, improved procedural outcomes, and zero bleeding complications, reinforcing its position as a next-generation solution in electrophysiology and cardiovascular interventions. This development comes at a time when minimally invasive cardiac procedures are rapidly expanding, increasing demand for efficient and safe vascular closure technologies that can handle larger sheath sizes and complex clinical scenarios.

Clinical Study Demonstrates Strong Safety and Efficacy

The study evaluated 574 patients undergoing catheter ablation for atrial arrhythmias and left atrial appendage closure procedures, making it one of the most comprehensive real-world analyses of venous closure systems in electrophysiology. Results showed that VASCADE MVP® XL achieved higher procedural success rates compared to its predecessor, along with a consistent safety profile and efficient hemostasis. Notably, the system reported 0% bleeding complications, a critical metric in large-bore access procedures where bleeding risks are significantly elevated.

The study’s retrospective, observational design reflects real-world clinical practice, further strengthening the relevance of the findings. These outcomes underscore the device’s ability to enhance patient safety while optimizing workflow efficiency, particularly in high-volume electrophysiology labs and increasingly in ambulatory surgical settings where speed and reliability are essential

FDA Label Expansion Supports Advanced Cardiac Procedures

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In March 2026, the U.S. Food and Drug Administration (FDA) granted expanded labeling approval for VASCADE MVP® XL, enabling its use with 10–14F inner diameter and up to 17F outer diameter sheaths. This expansion is particularly significant as it aligns with the growing adoption of advanced cardiac technologies, including pulsed field ablation (PFA) systems and left atrial appendage closure devices.

The system is now the only extravascular venous closure device clinically proven for use in electrophysiology procedures involving large-bore sheaths up to 17F, positioning it as a unique and highly competitive solution in the market. The approval was supported by data from the AMBULATE EXPAND trial, a multicenter study confirming the system’s safety and effectiveness in complex clinical environments, further validating its role in modern cardiovascular care.

Innovation Driving Future of Electrophysiology Care

The VASCADE MVP® XL system is designed to support the evolving electrophysiology landscape, where procedures are becoming more complex and increasingly performed in cost-sensitive outpatient settings. By enabling fast, reliable venous closure without complications, the device helps clinicians deliver high-quality care while improving operational efficiency. Additional supporting data, including imaging-based assessments of vascular healing, have demonstrated encouraging outcomes even in high-risk, fully anticoagulated patients, further emphasizing its clinical value.

Experts believe that technologies like VASCADE MVP® XL will play a critical role in shaping the future of minimally invasive cardiac interventions, particularly as healthcare systems shift toward value-based care models. With ongoing presentations at major scientific meetings such as Heart Rhythm 2026, Haemonetics continues to strengthen its leadership in innovative medical technologies that enhance patient outcomes and procedural success.

Source: Haemonetics press release