LivaNova Unveils Essenz In-Line Blood Monitor with U.S. FDA 510(k) Clearance and CE Mark
31 8월 2023 - 5:05AM
Business Wire
LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology
company, today announced it received U.S. Food and Drug
Administration (FDA) 510(k) clearance and CE Mark for its
Essenz™ In-Line Blood Monitor (ILBM), which provides
accurate and continuous measurement of essential blood parameters
to perfusionists throughout cardiopulmonary bypass (CPB)
procedures. The ILBM is integrated into LivaNova’s next-generation
CPB platform, the Essenz™ Perfusion System, which allows
perfusionists to access and manage reliable blood parameters
directly from the system’s cockpit, without the need for additional
monitors or holders.
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Essenz In-Line Blood Monitor shown with
the Essenz Perfusion System (Photo: Business Wire)
Existing blood gas analyzers only reflect a patient’s clinical
condition at the exact moment a sample is drawn, which can quickly
change and become irrelevant.1,2 With the Essenz ILBM,
perfusionists receive in-line continuous monitoring of the
patient’s parameters for the duration of a procedure. This allows
for the delivery of a patient-tailored approach to perfusion rooted
in data-driven decisions.
“Dynamic conditions can rapidly change a patient’s blood
parameters during a cardiopulmonary bypass procedure,” said Marco
Dolci, LivaNova President, Cardiopulmonary. “The Essenz In-Line
Blood Monitor provides continuous monitoring throughout a patient’s
procedure. Access to accurate, real-time measurements directly from
the Essenz Perfusion System allows for quick decisions and tailored
care strategies to serve the patient.”
Powered by the proven B-Capta™ sensing technology, the Essenz
ILBM is the only in-line blood monitoring system that works within
Clinical Laboratory Improvement Amendments (CLIA) guidelines and
provides parameter values in line with hospital blood gas
analyzers, even prior to alignment.3 To enable accurate monitoring,
the ILBM provides measured values for oxygen saturation,
hematocrit, partial pressure of oxygen and temperature, rather than
calculated values for these parameters.
In addition, Essenz ILBM requires no calibration to set device
measurements, allowing the perfusionist to save time during device
set up, especially in emergency cases. Arterial and venous
parameters are automatically transferred to the Essenz™ Patient
Monitor, supporting data-driven decision making and the
implementation of goal-directed perfusion (GDP), a therapy
effective in reducing the risk of acute kidney injury.4 The latest
heart-lung machine software, version 1.3, integrates the ILBM with
the Essenz Perfusion System and was developed to continually
enhance the user experience.
Based on 50 years of trusted partnership, the Essenz Perfusion
System was designed and developed in collaboration with more than
300 customers worldwide. It consists of a next-generation
heart-lung machine (HLM), a patient monitor and accurate sensing
technology that now includes the ILBM. The Essenz Perfusion System
is currently available in Europe, the U.S., Canada, Australia,
Japan and the United Arab Emirates. Since its launch in February
2023, more than 1,000 patients worldwide have been supported with
this system. Learn more about the entire Essenz Perfusion System on
the LivaNova website.
View the Essenz Perfusion System brand video here.
*Note: The Essenz HLM is not available for sale in all
geographies. Visit the LivaNova website for important safety
information.
References
- Ottens J. et all. Improving Cardiopulmonary
Bypass: Does Continuous Blood Gas Monitoring Have a Role to Play? -
JECT. 2010;42:191–198
- Trowbridge CC et al., The Effects of
Continuous Blood Gas Monitoring During Cardiopulmonary Bypass: A
Prospective, Randomized Study-Part II, The Journal of
Extracorporeal Technology, 2000
- Perfusion, 2022, Vol. 0(0) 1–7, Marloes van
Hoeven, Eddy Overdevest, Joyce Curvers, Henri van Heugten: A
comparison of continuous blood gas monitors during cardiopulmonary
bypass LivaNova B-Capta, Terumo CDI 500, spectrum medical M4
- Goal-Directed Perfusion to reduce Acute Kidney
Injury: A Randomized Trial Ranucci M. et al. J Thorac Cardiovasc
Surg. 2018 Nov; 156(5): 1918-1927.e2.
doi.org/10.1016/j.jtcvs.2018.04.045
About LivaNova
LivaNova PLC is a global medical technology company built on
nearly five decades of experience and a relentless commitment to
provide hope for patients and their families through medical
technologies, delivering life-changing improvements for both the
Head and Heart. Headquartered in London, LivaNova employs
approximately 2,900 employees and has a presence in more than 100
countries for the benefit of patients, healthcare professionals and
healthcare systems worldwide. For more information, please visit
www.livanova.com.
Safe Harbor Statement
This news release contains “forward-looking statements”
concerning the Company’s goals, beliefs, expectations, strategies,
objectives, plans and underlying assumptions and other statements
that are not necessarily based on historical facts. These
statements include, but are not limited to, statements regarding
the Essenz Perfusion System, Essenz HLM, the Essenz Patient Monitor
and the Essenz ILBM. Actual events may differ materially from those
indicated in our forward-looking statements as a result of various
factors, including those factors set forth in Item 1A of the
Company’s most recent Annual Report on Form 10-K, as supplemented
by any risk factors contained in Quarterly Reports on Form 10-Q and
Current Reports on Form 8-K. LivaNova undertakes no obligation to
update the information contained in this press release to reflect
subsequently occurring events or circumstances.
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LivaNova Investor Relations and Media Contacts
+1 281-895-2382 Briana Gotlin Director, Investor
Relations InvestorRelations@livanova.com
Deanna Wilke VP, Corporate Communications
Corporate.Communications@livanova.com
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