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Haemonetics Corp's (NYSE: HAE) Vascade MVP Venous Vascular Closure System becomes the first vascular closure device to receive FDA indication for same-day discharge following atrial fibrillation (AF) ablation.
The Same-Day Discharge labeling was granted following the conclusion of the first two registries in the AMBULATE Same-Day Discharge (SDD) clinical study series.
As of July 2021, Cardiva Medical Inc completed three of its four planned registries in the AMBULATE Same-Day Discharge Clinical Study Series in almost 850 subjects.
Approximately 99% of subjects treated for AF with venous closure using the Vascade MVP were sent home the same day without additional intervention post-discharge.
Vascular access safety in all three studies was similar to that in the AMBULATE Pivotal Study.
Same-Day Discharge #3, an all-comers study for patients undergoing AF ablation with venous closure using VASCADE MVP, will begin enrollment in 2022. It is planned to be a multi-center prospective registry of 300 subjects.
Related content: Benzinga's Full FDA Calendar.
Price Action: HAE stock closed 0.18% higher at $70.59 on Thursday.
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