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
Fi Expands International Footprint to 38 Countries Worldwide2.6.2026 20:25:00 EEST | Press release
Fi, the leader in smart pet technology, today announced a major international expansion, bringing its AI-powered GPS pet wearables and connectivity network to 38 countries across North America and Europe. Fi devices are now available for purchase in 29 markets, including newly added countries such as Finland, Sweden, Denmark, Austria, Belgium, the Netherlands, Romania, Slovakia, and Latvia. Through Fi's international connectivity network, customers can also use Fi in Switzerland, Norway, Liechtenstein, Iceland, and Turkey, bringing Fi's total coverage footprint to 38 countries. The expansion reflects growing demand from pet owners who want reliable connectivity and health insights, whether they're at home or traveling abroad. "Wherever your pet roams, Fi should work," said Jonathan Bensamoun, Founder and CEO of Fi. "As more pet owners travel internationally and expect seamless connectivity, we're expanding Fi's footprint to help them stay connected to their pets across more of Europe a
XFolio AI Acquires Absolute Payment Solutions to Unify Treasury and Payments for UK Corporates2.6.2026 20:16:00 EEST | Press release
XFolio AI (xfolio.ai), a Paris-based treasury and cash management technology group, has acquired Absolute Payment Solutions (APS) (https://www.absolutepayments.com/), one of a select number of Pay.UK-accredited Bacs service providers in the UK. This acquisition creates an integrated platform spanning Bacs and all payment types, open banking, risk management, and treasury—giving UK corporates of all sizes the tools to manage cash and execute payments in one place. APS’s Bacs accreditation underpins payment services relied upon daily by organisations across both the public and private sectors, from SMEs running payroll and direct debit collections to large corporates processing high-volume payment flows. While enterprise payment platforms often demand significant scale and budget, and lighter solutions trade capability for speed of setup, APS and XFolio together deliver accredited Bacs infrastructure combined with advanced treasury intelligence across SWIFT, API, H2H, and EBICS rails—wit
Amazfit Introduces a New Era of Hybrid Training with Balance 3 and Balance Ultra2.6.2026 20:00:00 EEST | Press release
Amazfit, a leading global smart wearable brand owned by Zepp Health, today unveiled the Amazfit Balance 3 and Amazfit Balance Ultra, the newest additions to the Balance series and the hero watches for Amazfit’s new Hybrid Training System, connecting performance tracking with intelligent training guidance through the Zepp App. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260602329170/en/ Built around how modern athletes train today, Balance 3 and Balance Ultra are designed for people balancing strength, endurance, recovery, work, stress, and daily life. The devices serve as the engine layer of the connected Hybrid Training ecosystem, capturing how users train, recover, and respond over time. The products were unveiled at a launch event in New York during a panel hosted by leading voices from the fitness and HYROX community. Built around how modern athletes train today, Balance 3 and Balance Ultra are designed for people bal
Mouser's Rise of the Robots Program Explores Humanoid Design Considerations2.6.2026 18:19:00 EEST | Press release
Mouser Electronics, Inc., the authorized global distributor with the newest electronic components and industrial automation products, today announced the latest installment of its Empowering Innovation Together (EIT) technology series, Rise of the Robots, which explores key technologies behind humanoid robots and their potential for transformation. The series shares how these robots have progressed from simple machinery to critical tools used in caregiving, industrial automation, education, and even in the harshest environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260602293561/en/ The latest EIT installment explores the engineering design process, system integration challenges, and the role of legacy infrastructure, safety, and ROI in shaping scalable humanoid robot deployment. While science fiction has long envisioned robots resembling humans, recent advances in sensing, actuation, AI, embedded computing, and pow
Blue Cloud Ventures Announces Final Close of Blue Cloud Ventures V2.6.2026 17:35:00 EEST | Press release
Blue Cloud Ventures (BCV), a venture growth firm focused on investing in enterprise software companies, announced the final close of its fifth fund, Blue Cloud Ventures V (BCV V). This milestone reinforces the firm’s continued mission to back category-defining companies that are poised to thrive in the age of AI. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260602186634/en/ At the core of BCV’s strategy is building deep conviction in and backing companies that possess the potential to define or reshape entire industries. With BCV V, the firm is doubling down on its AI-first investment thesis, aiming to back and support visionary teams on their long-term growth journey as they build the systems that will serve as the backbone of the modern enterprise. Blue Cloud typically invests between $10 and $30 million as a lead, co-lead, or co-investor. Beyond support with strategy, recruiting, and customer introductions, the firm pro
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