Haemonetics Corporation has announced the publication of a study in the open-access journal Heart Rhythm O2 providing new evidence supporting the safety and efficacy of its Vascade MVP XL venous vascular closure system in large-bore sheath procedures.
The retrospective cohort study represents the largest reported cohort using the VASCADE MVP XL system to date, Haemonetics says in a press release.
Conducted at Emory University (Atlanta, USA) and funded by a grant from Haemonetics, the single-centre retrospective study evaluated real-world outcomes in 1,623 patients who received the Vascade MVP XL system following large bore (maximum 17Fr outer diameter (OD) sheaths) venous access electrophysiology procedures, including pulsed field ablation (PFA) for atrial fibrillation (AF), left atrial appendage closure (LAAC) or concomitant procedures.
Results demonstrated that the Vascade MVP XL system achieved rapid haemostasis (median 2 minutes), a 92.5% same-day discharge rate with a median time to discharge of 3.5 hours, and a strong safety profile with 1.2% overall vascular complications with no surgical interventions required.
“With real-world clinical evidence from a large and diverse patient population, we continue to demonstrate the Vascade MVP XL system’s consistent performance in large-bore venous closure,” said Ken Crowley, vice president and general manager, Interventional Technologies at Haemonetics. “As physicians seek innovative closure technologies to help improve clinical outcomes and patient experiences across PFA, LAAC and concomitant procedures, Vascade MVP XL is providing electrophysiology teams with a safe, reliable and effective solution delivering rapid haemostasis and enabling same-day discharge.”
The study’s corresponding author, David B De Lurgio, medical director of electrophysiology at Emory Saint Joseph’s Hospital and professor of medicine at Emory University School of Medicine, said: “What is particularly notable is that same-day discharge was consistently achieved, even with sheaths larger than historically used in device-based closure. With more than 1,600 patients in this cohort, the findings provide additional real-world evidence across a broad range of patients and procedures, including those with higher comorbidities in LAAC and concomitant cases.”
In March 2026, the US 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 OD procedural sheaths.
FDA approval was supported by clinical evidence from the AMBULATE EXPAND trial, demonstrating that the Vascade MVP XL system achieved rapid haemostasis with no complications and enabled same day discharge. Vascade MVP XL is the only extravascular venous closure system clinically proven in electrophysiology procedures using up to 17Fr OD procedural sheaths.
