Haemonetics today said that it has received FDA approval for same-day discharge after atrial fibrillation ablation using its Vascade MVP venous vascular closure system.
Vascade MVP is a vascular closure system that is designed for procedures that require multiple access site venous closures. It uses 6 to 12 Fr inner diameter sheaths that are commonly used in cardiac electrophysiology procedures to enable earlier ambulation, earlier discharge eligibility and a higher patient satisfaction, according to the Boston-based company.
“COVID has accelerated the need to enhance safety and efficacy to optimize the patient experience in meaningful ways. Vascade MVP earning the first and only indication for same-day discharge for AF ablation patients speaks to our industry leadership and continued commitment to improving the standards of care,” CEO and President Chris Simon said in a news release.
The same-day discharge labeling was granted following the company’s two registries in the Ambulate Same-Day Discharge clinical study series, in which the safety and efficacy of the Vascade MVP was studied for same-day discharge of AFib ablation patients. Cardiva Medical — acquired by Haemonetics this year — has completed three out of its four planned registries in the Ambulate study series.
Haemonetics first study was a multi-center retrospective study that enrolled 497 subjects across four U.S. centers, and the second was a prospective, multi-center, single-arm study under the name Same-Day Discharge (SDD) #1. It enrolled 151 paroxysmal AFib patients at eight U.S. centers. The company’s most recent Ambulate SDD #2 study was a multi-center, prospective, single-arm study with 203 enrolled patients who had persistent AFib.
The studies each demonstrated:
– Retrospective study: 99.4% of subjects who were treated for AFib with venous closure using the Vascade MVP were sent home the same day without additional intervention post-discharge.
– SDD #1: 98.6% of subjects who were treated for paroxysmal AFib with venous closure using the Vascade MVP were sent home the same day without additional intervention post-discharge.
– SDD #2: 99.5% of subjects who were treated for persistent AFib with venous closure using the Vascade MVP were sent home the same day without additional intervention post-discharge.
Vascular access safety in each study was similar to the results in the Ambulate pivotal study, which showed no major access site-related complications, according to Haemonetics.
“By using Vascade MVP following AFib ablation, the Ambulate SDD clinical study investigators achieved reproducible, consistent and durable vascular closure, facilitating same-day discharge,” principal investigator on the study Zayd Eldadah said in a news release.
The company will start enrollment for an SDD #3 study in 2022 with plans for a multi-center prospective registry of 300 subjects.