BOSTON, July 30,
2024 /PRNewswire/ -- Haemonetics Corporation (NYSE:
HAE), a global medical technology company focused on delivering
innovative medical solutions to drive better patient outcomes,
today announced CE Mark certification and the first commercial
European procedures for the SavvyWire® Pre-Shaped
Pressure Guidewire. The SavvyWire guidewire is the world's first
and only sensor-guided 3-in-1 solution for Transcatheter Aortic
Valve Implantation (TAVI), designed to improve procedural
efficiency with predictable wire performance, hemodynamic
measurement and left-ventricular (LV) pacing capabilities.
The certification will allow Haemonetics, which added the
SavvyWire guidewire to its product portfolio with its acquisition
of OpSens Inc. in December 2023, to
engage in the next steps of country-specific entrance of the
SavvyWire guidewire into the European Union (EU) and other
geographies that recognize CE marking. The first commercial
European procedures using the SavvyWire guidewire were performed
this month at Hôpital Haut-Lévêque du Centre Hospitalier
Universitaire (CHU) de Bordeaux,
France, and at Catharina Ziekenhuis Eindhoven in
The Netherlands.
The SavvyWire guidewire is engineered to uniquely support
multiple steps over the same guidewire, reducing procedural device
exchanges, providing stable aortic valve delivery and positioning
while continuously monitoring cardiac hemodynamics. Additionally,
it has been designed to enable reliable LV pacing without need for
adjunct devices or venous access for conventional right ventricular
pacing during TAVI procedures.
"More than 20 years after the first introduction of TAVI in
France, the SavvyWire guidewire
brings unique capabilities to European markets to help further
streamline and optimize the procedure through efficient,
predictable wire performance and LV pacing," said Dr. Lionel Leroux from CHU Bordeaux. Professor
Thomas Modine of CHU Bordeaux added,
"This wire marks an important step in the assessment of TAVI
patients. With one wire in the same position, there are less
manipulations and we are enabled to continuously monitor the
patient's haemodynamics."
According to Professor Pim Tonino
from Catharina Ziekenhuis Eindhoven, "The SavvyWire guidewire
raises the standard for hemodynamic measurements throughout the
TAVI procedure, enabling physicians to make important procedural
decisions immediately without having to exchange devices."
"CE Mark certification for the SavvyWire guidewire is a key step
in our strategic international expansion, as we continue to broaden
our leadership and impact by creating greater access to critical
interventional technologies that advance healthcare standards,"
said Stewart Strong, President,
Global Hospital at Haemonetics. "We look forward to leveraging our
strong global commercial infrastructure to bring the SavvyWire
guidewire's fiber optic sensor technology to Europe, the Middle
East and Africa, and enable
more physicians to optimize TAVI procedures to improve patient
outcomes."
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 SavvyWire guidewire and Haemonetics' plans or
objectives related to the commercialization of such 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 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.
Investor
Contacts:
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Olga Guyette, Vice
President-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, Senior
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