Jan Hartmann: FDA Has Approved An Expanded Indication for Haemonetics VASCADE MVP XL
Jan Hartmann, Chief Medical Officer at Haemonetics, shared on LinkedIn:
”Happy to share an important milestone for VASCADE MVP®XL.
The U.S. FDA has approved an expanded indication for Haemonetics MVP®XL, supporting venous closure for procedures using up to 17F outer diameter sheaths, including use with leading PFA and LAAC technologies – allowing more patients to benefit from the unique extravascular design and performance of MVP® XL.
The approval was supported by data from the AMBULATE EXPAND pivotal trial, which demonstrated:
- 0% major access‑site closure–related complications
- 0% minor access‑site closure–related complications
- Median time to ambulation of 2.4 hours
- Median time to hemostasis of 2.3 minutes
These results underscore the clinical value of reliable, large‑bore venous closure.
A sincere thank you to the patients who participated in the clinical trial, and to the investigators and site teams whose rigorous work provided this important evidence.
The pivotal trial results were presented at AF Symposium 2026 in Boston earlier this year, with the ultrasound substudy data to be shared at the Heart Rhythm Society meeting next month in Chicago.
Proud of the clinical science and teamwork behind this advancement!”
Title: Safety and Efficacy of the VASCADE MVP® XL Venous Vascular Closure System for Management of Femoral Venotomy Following Catheter-Based Interventions Utilizing 16-17F OD Sheaths: The AMBULATE EXPAND Trial
Authors: Hugh Thomas McElderry, Amin Al-Ahmad, David De Lurgio, T. Jared Bunch, Zayd A. Eldadah, Maheer Gandhavadi, Bruce Hook, Joseph Banno, Suneet Mittal
Read the Full Article on Journal of Cardiovascular Electrophysiology
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