Haemonetics Corporation has 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. The study 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 (LAAC) procedures.
The study included some procedures in which Vascade MVP was used outside the scope of its approved indication, which is for use with 6-12Fr 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 haemostasis without complications, including 0% bleeding complications.
In March 2026, the U. Food and Drug Administration (FDA) approved expanded labelling for the Vascade MVP XL venous vascular closure system to include procedures using 10-14Fr inner diameter (ID) and up to 17Fr outer diameter (OD) procedural sheaths. With this label expansion, the Vascade MVP XL system is approved for larger sheaths used in technologies for pulsed field ablation (PFA) to treat atrial fibrillation such as Boston Scientific’s Farapulse and LAAC systems, including Boston Scientific’s Watchman TruSteer.
FDA approval was supported by clinical evidence from the AMBULATE EXPAND trial, a multicentre, prospective, single-arm, pivotal trial designed to evaluate the safety and effectiveness in technologies using 17Fr maximum OD procedural sheaths. The study results were published in the Journal of Cardiovascular Electrophysiology in March 2026. 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, 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.”
