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, which was acquired by Haemonetics earlier 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.