Haemonetics Announces VASCADE MVP® Venous Vascular Closure System Gains the First and Only FDA Approval for Same-Day Discharge Following Atrial Fibrillation Ablation
BOSTON, Sept. 30, 2021 /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative medical solutions to drive better patient outcomes, announced that the VASCADE MVP® Venous Vascular Closure System is now the first and only 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, which evaluated the safety and efficacy of using VASCADE MVP to facilitate same-day discharge of AF ablation patients. As of July 2021, Cardiva Medical Inc., an industry-leading manufacturer of vascular closure systems acquired by Haemonetics earlier this year, has completed three of its four planned registries in the AMBULATE Same-Day Discharge Clinical Study Series.
The first study was a multi-center retrospective study that enrolled 497 subjects across four U.S. centers, and the second study was a prospective, multi-center, single-arm study, referred to as SDD #1. SDD #1 enrolled 151 paroxysmal AF patients at eight U.S. centers under the direction of 27 investigators. The most recent study, AMBULATE Same-Day Discharge #2, was a multi-center, prospective, single-arm study that enrolled 203 persistent AF patients at 13 U.S. centers under the direction of 37 investigators. The studies demonstrated the following:
Vascular access safety in all three studies was similar to that in the AMBULATE Pivotal Study, i.e. zero major access site-related complications. 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.
"By using VASCADE MVP following AF ablation, the AMBULATE SDD Clinical Study investigators achieved reproducible, consistent and durable vascular closure, facilitating same-day discharge," said Zayd A. Eldadah, M.D., Ph.D., Principal Investigator and Director of Cardiac Electrophysiology at the MedStar Health System, based in the Baltimore, MD – Washington, DC region.
VASCADE MVP is the only marketed vascular closure system proven and labeled specifically for procedures requiring multiple access site venous closure with standard 6-12 French inner diameter (15 French maximum outer diameter) sheaths used in cardiac electrophysiology procedures. In previous studies, VASCADE MVP has been proven to enable earlier ambulation, earlier discharge eligibility and higher patient satisfaction.
According to Chris Simon, Haemonetics' President and CEO, "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."
Cautionary Note Regarding Forward Looking Statements
Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, product quality; market acceptance; the effect of economic and political conditions; the impact of the COVID-19 pandemic, including the scope and duration of the pandemic, government actions and restrictive measures implemented in response; the impact of competitive products and pricing; and vascular closure product reimbursement policies and practices. These and other factors are identified and described in more detail in the Company's periodic reports and other filings with the U.S. Securities and Exchange Commission. The Company does not undertake to update these forward-looking statements.
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SOURCE Haemonetics Corporation
Company Codes: NYSE:HAE