LivaNova Unveils Essenz In-Line Blood Monitor with U.S. FDA 510(k) Clearance and CE Mark
30.8.2023 23:05:00 EEST | Business Wire | Press release
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
Focused Support Launches Cavok STRIKE to Expand Link-16 Participation Across the Joint Force14.9.2026 08:00:00 EEST | Press release
Focused Support LLC today announced the launch of Cavok STRIKE, an integrated software capability that expands the Link-16 tactical battlespace picture by enabling additional operational platforms to participate in the Link-16 network. Modern battlefields have increasing numbers of unmanned systems, sensors, and supporting platforms operating throughout the joint battlespace. The rapid proliferation of Group 1, 2, and 3 UAS, including both expendable and recoverable systems, has created a growing need to integrate these assets into the broader tactical network. Many of these platforms provide operationally relevant information but have historically remained outside the Link-16 network due to limitations in size, weight, power, platform integration complexity, or acquisition cost. Cavok STRIKE addresses this gap by enabling platforms to participate in the Link-16 network as non-command-and-control participants. This allows those platforms to interoperate with traditional Link-16 platfor
Fujirebio Expands Access to Blood-based Neurology Testing in Brazil with ANVISA Market Authorization for Lumipulse® G NfL Blood and Lumipulse G pTau 217 Plasma14.9.2026 08:00:00 EEST | Press release
H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio today announced that the Brazilian Health Regulatory Agency (ANVISA) has granted market authorization for the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays for use on the fully automated LUMIPULSE® G immunoassay platform in Brazil. “ANVISA authorization of the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays marks another important step in our mission to expand access to reliable, clinically meaningful blood-based biomarkers for clinicians and patients worldwide,” said Christiaan De Wilde, CEO of Fujirebio Europe N.V. “By making both neurological biomarker assays available to laboratories on a single, fully automated platform, we are helping support more informed clinical decision-making across a broad range of neurological conditions and throughout the diagnostic pathway.” The Brazilian ANVISA authorizations are based on the already CE marked in vitro diagnostics (IVD) approvals of these two
MEX Exchange, Part of MultiBank Group, Expands Executive Team as International Growth Accelerates14.9.2026 08:00:00 EEST | Press release
MEX Exchange, the institutional electronic trading platform of MultiBank Group, has announced the appointment of Brian Liedberg as Chief Revenue Officer and Global Head of Sales, strengthening its commercial leadership as the company continues to develop its institutional trading business and expand its presence across international markets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260913319267/en/ Brian Liedberg joins MEX Exchange, bringing more than 30 years of experience across global capital markets, electronic trading and FinTech Liedberg brings more than 30 years of experience across global capital markets, electronic trading and financial technology, with a career spanning institutional sales, business development, commercial strategy and revenue growth. Prior to joining MEX Exchange, Liedberg served as Head of Global Sales and Chief Revenue Officer at TradAir, where he led the company’s global commercial growth
Signaloid Announces Appointment of Quantitative Finance and Cloud Veterans to Advisory Board and Senior Commercialization Roles14.9.2026 06:00:00 EEST | Press release
British technology company Signaloid today announced the appointment of three distinguished industry veterans to its advisory board and senior leadership roles, to strengthen the commercialization momentum behind its technology: Dr. Han Lee, former Global Head of Quantitative Strategies and Automated Trading for the Fixed Income Division at Morgan Stanley, Dr. Nachiketh Potlapally, former Architect at Oracle Cloud Infrastructure, and Christian Roth, former Senior Director Enterprise Sales, Intel. Bringing deep expertise in quantitative finance and cloud infrastructure, the appointments build on Signaloid’s commercial traction momentum in Europe, Japan, and the United States. Dr. Lee, prior to his executive role at Morgan Stanley, served as Global Head of Quantitative Analytics at RBS and holds a Ph.D. in Theoretical Physics from the University of Cambridge. He is a co-founder of RLxPartners Ltd, and serves as an advisor to the Head of the Department of Physics at the University of Oxfo
SES’s Final Three O3b mPOWER Satellites Successfully Launched13.9.2026 23:22:00 EEST | Press release
SES today announced the successful launch of its eleventh, twelfth and thirteenth O3b mPOWER satellites, further expanding its second-generation medium Earth orbit (MEO) system designed to offer high-performance connectivity services around the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260913914517/en/ SES’s Final Three O3b mPOWER Satellites Successfully Launched The three satellites launched at 2:49 pm local time aboard a SpaceX Falcon 9 rocket from Space Launch Complex 40 (SLC-40) at Cape Canaveral Space Force Station. “This launch marks a defining milestone for SES as we complete the O3b mPOWER constellation and further strengthen our MEO capabilities,” said Adel Al-Saleh, CEO of SES. “More importantly, it reinforces our ability to deliver resilient, secure and scalable connectivity for customers around the world, helping governments, enterprises, cloud providers and mobility customers meet their most critical
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