BOSTON, April 4,
2024 /PRNewswire/ -- Haemonetics Corporation (NYSE:
HAE), a global medical technology company focused on delivering
innovative medical solutions to drive better patient outcomes,
announced today that it has received 510(k) clearance from the U.S.
Food and Drug Administration (FDA) for the TEG® 6s
hemostasis analyzer system Global Hemostasis-HN assay cartridge.
This new cartridge extends Haemonetics' TEG 6s viscoelastic testing
capabilities to serve fully heparinized patients in adult
cardiovascular surgeries/procedures and liver transplantation in
both laboratory and point-of-care settings.
"TEG testing provides critical information that can help
physicians improve hemostasis management for their patients,
especially in critical situations like open heart and liver
transplant surgeries and major trauma," said Jan Hartmann, MD, Senior Vice President and
Chief Medical Officer at Haemonetics. "The Global Hemostasis-HN
assay cartridge expands the benefits of TEG 6s system to patients
on cardiopulmonary bypass or undergoing liver transplantation where
heparin or endogenous heparinoids are present."
Understanding a patient's complete hemostasis status quickly can
have a significant impact on clinical outcomes and use of blood
products. Haemonetics' cartridge-based TEG 6s system provides
clinicians a complete picture about a patient's coagulation
profile, with faster, more detailed information for actionable
results compared to conventional coagulation testing. The TEG 6s
analyzer is supported by TEG Manager® software that
enables remote real-time viewing of results throughout the
hospital, as well as Interpretation Guidance with customizable
alert messages. Haemonetics is planning to release the new Global
Hemostasis-HN cartridge for TEG 6s system in the coming months.
The 510(k) clearance was supported by clinical data from a
multi-center trial that included 335 patients undergoing cardiac
bypass surgeries, interventional cardiology procedures or liver
transplantations. An additional study was conducted using 164
healthy volunteers to establish the normal reference ranges for the
test cartridge. Overall, over 5,500 clinical data points were used
to demonstrate safety and effectiveness of the Global Hemostasis –
HN assays.
"Our market-leading TEG 6s platform has helped Haemonetics make
effective and efficient viscoelastic testing more accessible
throughout the world," said Stewart
Strong, President, Global Hospital at Haemonetics. "With our
new cartridge we look forward to expanding the impact of our Blood
Management Technologies franchise through increased adoption of TEG
6s, and helping more clinicians improve patient outcomes and
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. Haemonetics'
Global Hospital business provides a range of solutions to address
the needs of hospitals, including Interventional Technologies for
electrophysiology and interventional cardiology, and Blood
Management Technologies that include diagnostics to help inform
treatment decisions, technologies to help avoid unnecessary
allogeneic transfusions and solutions to help optimize management
of blood products. To learn more about Haemonetics,
visit www.haemonetics.com.
Cautionary Statement Regarding Forward-Looking
Information
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 TEG 6s hemostasis analyzer system Global Hemostasis-HN assay
cartridge and Haemonetics' plans or objectives related to the
commercialization of such product enhancement. 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 global economic and political conditions; and the
impact of competitive products and pricing. These and other factors
are identified and described in more detail in Haemonetics'
periodic reports and other filings with the U.S. Securities and
Exchange Commission. Haemonetics does not undertake to update these
forward-looking statements.
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Investor
Contacts:
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Olga Guyette, Sr.
Director-Investor Relations & Treasury
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David Trenk,
Manager-Investor Relations
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(781)
356-9763
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(203)
733-4987
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olga.guyette@haemonetics.com
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david.trenk@haemonetics.com
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Media
Contact:
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Josh Gitelson,
Director-Global Communications
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(781)
356-9776
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josh.gitelson@haemonetics.com
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SOURCE Haemonetics Corporation