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
Al Barari Breaks Ground on The Cape, The Final Chapter of a Legacy6.2.2026 16:46:00 EET | Press release
Al Barari, Dubai’s pioneering nature-led community, has officially marked the groundbreaking of The Cape, its final signature residential development, celebrating two decades of visionary craftsmanship and a continued commitment to creating harmonious living environments rooted in nature. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260206475199/en/ Hazza Zaal, CEO of Al Barari Real Estate Group, alongside the Sales and Construction teams at The Cape Groundbreaking Ceremony, marking a milestone in Al Barari’s final signature development. (Photo: AETOSWire) The milestone ceremony signals the beginning of a landmark chapter for Al Barari, as The Cape represents the culmination of a 20-year legacy defined by intentional design, wellbeing-focused living, and immersive natural landscapes. Located within Dubai’s green heart, The Cape introduces an enriched lifestyle experience surrounded by lush botanical settings, gentle water
Quantfury and Sandwich Launch Commercial Series to Encourage Better Choices in Retail Trading6.2.2026 16:00:00 EET | Press release
Quantfury Trading Americas Limited (“Quantfury”), a global brokerage offering commission-free trading at real-time spot prices from major exchanges, has partnered with Sandwich, a leading creative agency for tech and product videos, to produce a Social Responsibility Commercial Series. The series of commercials incorporates clear, engaging storytelling to prompt viewers to think about common retail trading behaviors—especially high-energy marketing, gamification of speculation, and heavy focus on potential gains without equal attention to risks—and to choose more thoughtful, informed approaches. Lev Mazur, Founder of Quantfury, said: “It’s a pleasure to work with Sandwich, whose visual storytelling is outstanding. Since day one, Quantfury has aimed to question and improve the standard practices in the global retail trading industry.” Adam Lisagor, Founder of Sandwich, added: “A good investment is a story. Quantfury stood out by wanting to tell a real, interesting story first—rather tha
JSS: 2025 Sake Exports Grew Steadily, Reaching a Record 81 Markets6.2.2026 05:00:00 EET | Press release
Sake exports continued to expand in 2025 in both value and volume, with export destinations reaching a record 81 countries and regions. Export value increased 6% year on year to 45.9 billion yen, while export volume rose 8% to 33.55 million liters (3.73 million cases on a 9-liter basis), marking the second-highest export performance on record. The average export unit price per 750 ml bottle declined 2% year on year to 1,026 yen. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260205671686/en/ Sake Export Performance by Country (Top 10, 2025) Export value has nearly doubled since 2020, and the CAGR over the past five years reached 14%. This underscores sake’s position as a high-growth category globally. Asia remained the largest export destination, with export value totaling 28.8 billion yen, representing an 8% increase year on year and accounting for 63% of total export value. North America recorded exports of 12.4 billion ye
Canva Brings On-Brand Designs Directly into AI Assistants6.2.2026 01:00:00 EET | Press release
The future of work is being rewritten by AI, with professionals accomplishing in minutes what used to take hours. But there's been one persistent breaking point in AI assistants: generic visual outputs and off-brand colors that undermine AI speed with tedious manual cleanup. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260205384226/en/ Canva Today, that friction ends as Canva brings brand intelligence directly into the AI tools where modern day work happens most. Starting now, ChatGPT users can create designs completely tied to their Canva Brand Kit, making a company’s brand come to life visually and function as a living participant in AI workflows. This expansion marks the coming together of Canva and ChatGPT, two category-defining platforms, in a new way to make on-brand design more accessible and fluid. From client-ready pitch decks to social posts and professional-looking posters, the partnership continues to fuel Canv
DNIB.com Reports Internet Has 386.9 Million Domain Name Registrations at the End of the Fourth Quarter of 20256.2.2026 00:04:00 EET | Press release
VeriSign, Inc. (NASDAQ: VRSN), a global provider of critical internet infrastructure and domain name registry services, today announced that, according to the latest Domain Name Industry Brief Quarterly Report from DNIB.com, the fourth quarter of 2025 closed with 386.9 million domain name registrations across all top-level domains (TLDs), an increase of 8.4 million domain name registrations, or 2.2% compared to the third quarter of 2025. Domain name registrations also increased by 22.7 million, or 6.2%, year over year. The .com and .net TLDs had a combined total of 173.5 million domain name registrations in the domain name base at the end of the fourth quarter of 2025, an increase of 1.6 million domain name registrations, or 0.9% compared to the third quarter of 2025. The .com and .net TLDs had a combined increase of 4.5 million domain name registrations, or 2.6%, year over year. As of Dec. 31, 2025, the .com domain name base totaled 161.0 million domain name registrations and the .net
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