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:
- Retrospective Study – 99.4% of subjects treated for AF with
venous closure using the VASCADE MVP were sent home the same day
without additional intervention post-discharge.
- SDD #1 - 98.6% of subjects treated for paroxysmal AF with
venous closure using the VASCADE MVP were sent home the same day
without additional intervention post-discharge.
- SDD #2 – 99.5% of subjects treated for persistent 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, 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."
About Haemonetics
Haemonetics (NYSE: HAE) is a global
healthcare company dedicated to providing a suite of innovative
medical products and solutions for customers, to help them improve
patient care and reduce the cost of healthcare. Our technology
addresses important medical markets: blood and plasma component
collection, the surgical suite and hospital transfusion services.
In 2021, Haemonetics acquired Cardiva Medical, Inc., a Santa
Clara-based industry-leading manufacturer focused on transforming
vascular closure for the benefit of patients, hospitals and
physicians in the over 5.5 million catheter-based coronary,
peripheral and electrophysiology procedures in the United States that require access site
closure each year. To learn more about Haemonetics, visit
www.haemonetics.com.
Cautionary Note Regarding Forward Looking
Statements
Any statements contained in this press release
that do not describe historical facts may constitute
forward-looking statements. Forward-looking statements in this
press release may include, without limitation, statements regarding
plans and objectives of management for the operation of
Haemonetics, including statements regarding potential benefits
associated with the VASCADE MVP® Venous Vascular Closure
System, and Haemonetics' plans or objectives related to the
development and commercialization of this product. Such
forward-looking statements are not meant to predict or guarantee
actual results, performance, events or circumstances and may not be
realized because they are based upon Haemonetics' current
projections, plans, objectives, beliefs, expectations, estimates
and assumptions and are subject to a number of risks and
uncertainties and other influences.
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.
Investor
Contact:
Olga Guyette,
Director-Investor Relations
(781)
356-9763
olga.guyette@haemonetics.com
|
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Media
Contact:
Josh Gitelson,
Director-Global Communications
(781)
356-9776
josh.gitelson@haemonetics.com
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SOURCE Haemonetics Corporation