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
Tacton Appoints Former IFS Executive Merlin Knott as Chief Commercial Officer to Accelerate Global Growth and Scale Beyond CPQ2.10.2026 16:00:00 EEST | Press release
Tacton, a global leader in Configure, Price, Quote (CPQ) software and configuration solutions for manufacturers of complex products, today announced the appointment of Merlin Knott as Chief Commercial Officer (CCO). In this role, Knott will lead Tacton’s global commercial organization, including marketing, sales, and pre-sales, aligning the teams responsible for bringing Tacton’s solutions to market, and driving value to its customers and partners globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261002794882/en/ Merlin Knott, Chief Commercial Officer, Tacton Knott joins Tacton with decades of experience building and scaling commercial organizations across the enterprise software industry. Most recently, he held senior leadership roles at IFS, the world’s leading provider of Industrial AI software, where he led global partner and channel operations before becoming President of the company’s Enterprise Service Manageme
EDW Presents 2026 Data Quality Award to Repeat Winner Domivest2.10.2026 16:00:00 EEST | Press release
European DataWarehouse (EDW) presented its fifth annual Data Quality Award at the 2026 TSI Congress in Berlin. This year, EDW's Best Data Quality – Deal of the Year (2026) award was presented to Domivest B.V. for its transaction Domi 2023-1 B.V., recognising the firm's outstanding commitment to accurate, complete, and consistent reporting. The award is based on EDW's proprietary data quality scoring methodology, which evaluates transactions against thousands of validation rules and checks. Data quality excellence is not a one-off achievement. The fact that the same issuers continue to rank among the top performers year after year demonstrates that superior data quality is the result of sustained commitment, robust processes, and ongoing investment. "Receiving the Data Quality Award for a second time means a great deal to us. Transparent, accurate loan-level data is key to investor trust in our transactions, and we are grateful to European DataWarehouse for recognising the work our trea
ILiAD Biotechnologies Expands BPZE1 Public Health and Commercial Potential with Publication of Pediatric Phase 2b Study in The Lancet Infectious Diseases2.10.2026 15:00:00 EEST | Press release
ILiAD Biotechnologies, Inc. (ILiAD), an advanced clinical stage biotech company focused on the prevention and treatment of disease caused by Bordetella pertussis, today announced the publication of results from its Phase 2b SUPER (Stand Up to Pertussis) clinical trial in The Lancet Infectious Diseases. This randomized, double blind, placebo- and active-comparator-controlled trial demonstrated that BPZE1, a live attenuated intranasal pertussis vaccine, induced robust nasal mucosal immune responses in healthy children aged 6 through 17 years (LINK). The study demonstrated that a single intranasal dose of BPZE1 induced nasal mucosal immune responses against all Bordetella pertussis antigens tested and was well tolerated, both when administered alone and when co-administered with a tetanus-diphtheria-acellular pertussis (Tdap) booster vaccine. The multi-center Phase 2b trial enrolled 366 participants across 16 sites in the United Kingdom, Australia, and Costa Rica and included participants
NIQ Brings New AI and Automation Capabilities to Retail Space Planning and Merchandising2.10.2026 13:45:00 EEST | Press release
NielsenIQ (NYSE: NIQ), a leading consumer intelligence company, today announced new AI and automation capabilities for NIQ Spaceman®, its retail space planning and merchandising platform trusted by more than 600 retailers across 65+ countries. The enhancements help retailers create store-specific planograms up to 50 times faster, identify execution and compliance gaps, and scale merchandising decisions across their store networks through expanded cloud-based access. "Retailers are under increasing pressure to localize assortments, execute consistently across stores, and respond more quickly to changing shopper behavior," said Natalie Williams, SVP, Product at NIQ. "These enhancements help simplify that process by embedding agentic AI directly into merchandising workflows and automating traditionally manual planning tasks. That means teams can spend less time building and updating planograms and more time acting on opportunities. With greater automation, retailers can improve productivi
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)2.10.2026 13:30:00 EEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to one senior leader and ten newly hired non-executive employees. The equity awards for the senior leader were granted on September 30, 2026 and consisted of options to purchase an aggregate of 121,800 shares and restricted share units covering an aggregate of 58,000 shares. The options have an exercise price per share equal to $12.44. The equity awards to the ten newly hired non-executive employees were granted on October 1, 2026 and consisted of options to purchase an aggregate of 97,100 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 46,200 shares. These options have an exercise price per share equal to $11.95, the closing price of the Company’s American De
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