LivaNova Unveils Essenz In-Line Blood Monitor with U.S. FDA 510(k) Clearance and CE Mark
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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230830793488/en/
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230830793488/en/
Contact information
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
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
CMA Approves Amendments to Investment Accounts Instructions to Strengthen Foreign Investor Access and Enhance Market Efficiency27.10.2025 19:29:00 EET | Press release
The Capital Market Authority (CMA) of Saudi Arabia has approved a set of amendments to the regulatory framework governing the procedures for opening and operating investment accounts. These changes aim to facilitate access for a broader base of foreign investors and align with the Kingdom's regulatory and technological developments. The amendments are part of CMA’s ongoing efforts to enhance the investment environment and expand the investor base in the Saudi capital market. The requirements for opening an investment account for individual foreign investors residing in one of the GCC countries have been developed. In addition, the scope of securities that they can directly invest in now includes the shares of listed companies on the Saudi Main Market (TASI). Before these facilitations, their access was limited to the debt instruments market, the Parallel Market (Nomu), investment funds, and the derivatives market. Furthermore, trading in the main market was previously restricted to bei
Carbon Measures and International Chamber of Commerce Launch Technical Expert Panel on Carbon Accounting27.10.2025 18:11:00 EET | Press release
Carbon Measures and the International Chamber of Commerce (ICC) today announced the formation of an independent expert panel that will work to develop the guidelines and implementation steps to establish a global carbon emissions accounting system based on financial accounting principles. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251027348594/en/ The Technical Expert Panel on Carbon Accounting will be comprised of experts from academia, financial accounting, industry and civil society, representing multiple perspectives and geographies. Together, they will define the principles, scope, and applications of a carbon emissions accounting system modeled on financial accounting principles. Such a system would provide accurate, transparent, verifiable, and timely company- and product-level data, ensuring every tonne of carbon emissions is counted only once and attributed correctly at each step of the value chain. The panel wi
IAMPHENOM Europe Expands All-Star Speaker Lineup27.10.2025 15:30:00 EET | Press release
Phenom, an applied AI company that helps organisations hire faster, develop better and retain longer, announced a second wave of confirmed speakers joining its inaugural IAMPHENOM Europe conference — the only applied AI event for human resources. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251027606156/en/ Phenom announced a second wave of confirmed speakers joining its inaugural IAMPHENOM Europe conference — the only applied AI event for human resources. Featuring visionary keynotes, customer-led breakout sessions, live demonstrations of use-case specific AI agents, and networking opportunities across HR and IT, the in-person event will take place 6 November in Munich. Session topics will include how to: assess AI and automation maturity levels; deploy 25+ AI agents; uphold compliance while navigating European regulations; develop and retain internal talent while attracting external skills; drive unprecedented recruiter
ThetaRay and Kaufman Rossin Announce AI AML Model Validation at Money20/20 USA27.10.2025 15:00:00 EET | Press release
ThetaRay, a global leader in Cognitive AI financial crime compliance, today announced that Kaufman Rossinhas completed an independent validation of its AML Transaction Monitoring and OFAC Screening Modules. Finalized in August 2025, the review confirms that ThetaRay’s AI models demonstrate the governance, transparency, and robustness regulators increasingly expect from AI-driven compliance systems. The announcement will be featured at Money20/20 USA, where the future of finance and compliance technology takes center stage. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251027724792/en/ A timely milestone in a shifting regulatory landscape In the United States, regulators are sharpening their focus on model risk management. FinCEN’s proposed modernization of the Bank Secrecy Act emphasizes dynamic, risk-based compliance programs and heightened oversight of third-party models. In the European Union, the newly enacted AI Act se
Klarna Launches Memberships: Premium Perks Without Expensive Credit27.10.2025 15:00:00 EET | Press release
Klarna, the global digital bank and payments provider, today unveiled its new global membership program, introducing Premium and Max. The program delivers premium benefits like cashback, travel perks, and lifestyle rewards in a transparent, monthly plan, without the need to take on expensive credit. The launch marks a major step in Klarna’s evolution into a full-scale digital bank helping consumers manage their money with greater value and control. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251027643962/en/ “We believe consumers shouldn’t have to take on expensive credit to access premium benefits,” said David Sandström, Chief Marketing Officer at Klarna. “For decades, exclusive perks such as airport lounge access, concierge-style subscriptions, and premium travel insurance were only available to elite credit card holders. Klarna is changing that. Through Klarna memberships, consumers can enjoy travel, lifestyle, and dig
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom