Haemonetics Corporation, a global medical technology company focused on delivering innovative solutions designed to improve patient outcomes, announced the publication of a new study comparing its VASCADE MVP XL vascular closure system with the VASCADE MVP venous vascular closure system in the context of large‐bore venous access closure procedures. This study, "VASCADE MVP-XL Versus VASCADE MVP for Large-Bore Venous Access-Site Closure in Electrophysiology Procedures: A Single-Centre Experience on Efficacy and Complications," was published earlier this week in the Journal of Cardiovascular Electrophysiology.
The retrospective, non-randomised, observational single-centre cohort study included a total of 574 consecutive patients undergoing catheter ablation for atrial arrhythmia or left atrial appendage closure procedures. The study included some procedures in which VASCADE MVP was used outside the scope of its approved indication, which is for use with 6-12F inner diameter procedural sheaths. Results demonstrated VASCADE MVP XL's superior performance in the context of these large‐bore venous access closure procedures, achieving higher procedural success, a more consistent safety profile, and efficient hemostasis without complications, including 0 per cent bleeding complications.
In March 2026, the U.S. Food and Drug Administration (FDA) approved expanded labelling for the VASCADE MVP XL venous vascular closure system to include procedures using 10-14F inner diameter (ID) and up to 17F outer diameter (OD) procedural sheaths. With this label expansion, the VASCADE MVP XL system is approved for larger sheaths used in market-leading technologies for pulsed field ablation (PFA) to treat atrial fibrillation, such as Boston Scientific's FARAPULSE and left atrial appendage closure (LAAC) solutions, including Boston Scientific's WATCHMAN TruSteer. VASCADE MVP XL is now the only extravascular venous closure system clinically proven in electrophysiology procedures using up to 17F OD procedural sheaths.
FDA approval was supported by clinical evidence from the AMBULATE EXPAND trial, a multicenter, prospective, single-arm, pivotal trial designed to evaluate the safety and effectiveness of technologies using 17F maximum OD procedural sheaths. The study results were published in the Journal of Cardiovascular Electrophysiology in March 2026. Additionally, findings from a prospective ultrasound sub‑study involving 31 patients were published in Heart Rhythm O2 yesterday and will be presented at the Heart Rhythm Society's Heart Rhythm 2026 in Chicago on Saturday, April 25, 2026, from 12:00 – 2:00 p.m. CT. This study provided an imaging‑based assessment of the closure site and demonstrated encouraging early vascular findings in a high‑risk, fully anticoagulated population, offering further insight into vascular healing following VASCADE MVP XL deployment.
"The expanded indication for the VASCADE MVP XL system supports the rapidly evolving electrophysiology landscape, including the adoption of next‑generation PFA and LAAC technologies and the growing number of concomitant procedures," said Jan Hartmann, M.D., Senior Vice President and Chief Medical Officer at Haemonetics. "By enabling reliable venous closure in large‑bore procedures, VASCADE MVP XL helps electrophysiology teams deliver safe, effective care across hospital‑based labs and increasingly time‑ and cost‑conscious outpatient settings, including ambulatory surgery centres."
