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
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)7.4.2026 23:30:00 EEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to seven newly hired non-executive employees. The equity awards were granted on April 1, 2026 and consisted of options to purchase an aggregate of 117,445 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 55,875 shares. The options have an exercise price per share equal to $5.62, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restricted s
SLB OneSubsea and Subsea7 Sign Collaboration Agreement with PETRONAS Suriname7.4.2026 23:05:00 EEST | Press release
Global energy technology company SLB (NYSE: SLB) today announced the signing of a strategic collaboration agreement between PETRONAS Suriname E&P B.V. (“PETRONAS Suriname”), a subsidiary of PETRONAS and Subsea Integration Alliance, comprising SLB OneSubsea and Subsea7. This partnership aims to unlock resources in Suriname’s emerging frontier basin through innovative and cost-effective subsea solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260331210557/en/ SLB OneSubsea has signed a strategic collaboration agreement between PETRONAS Suriname E&P B.V. (“PETRONAS Suriname”), a subsidiary of PETRONAS and Subsea Integration Alliance, comprising SLB OneSubsea and Subsea7. This partnership aims to unlock resources in Suriname’s emerging frontier basin through innovative and cost-effective subsea solutions. The agreement establishes a long-term framework for collaboration across the project lifecycle. This approach enables
Nadia Karkar Joins 500 Global as Managing Partner7.4.2026 20:43:00 EEST | Press release
500 Global today announced the appointment of Nadia Karkar as Managing Partner as the firm expands its global investment platform. Nadia’s appointment follows the recent announcement of the appointment of Atul Mehta — former Chief Investment Officer of the International Finance Corporation — to 500 Global's Board of Directors, and reflects the firm's continued build-out of the leadership and capabilities required to deliver on its next stage of global growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260407719214/en/ Nadia Karkar Joins 500 Global as Managing Partner Nadia joins from TPG Rise, the $31 billion impact investing platform of TPG Inc., where she most recently served as Head of Business Development, responsible for product innovation, strategic partnerships and corporate development. She played a central role in building TPG Rise Climate’s Global South Initiative, a blended finance vehicle designed to catalyze
Mouser Electronics Explores How Artificial Intelligence Shapes Everyday Technologies and Experiences7.4.2026 18:11:00 EEST | Press release
Mouser Electronics, Inc., the authorized global distributor with the newest electronic components and industrial automation products, today announced the first 2026 installment of its Empowering Innovation Together (EIT) technology series, Engineering AI for Daily Life. This installment explores how artificial intelligence is increasingly embedded in everyday products and services, from assisted search and messaging tools to healthcare wearables that monitor personal well-being. As AI capabilities expand across consumer and connected devices, engineers continue to design systems that make these technologies more useful, intuitive, and trustworthy in real-world applications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260407524737/en/ This installment of Empowering Innovation Together explores how AI is increasingly embedded in everyday products and services, from assisted search and messaging tools to healthcare wearables
Umrah and Ziyarah Forum Concludes in Madinah with Landmark Achievements in Pilgrim Services7.4.2026 17:38:00 EEST | Press release
Under the generous patronage of His Royal Highness Prince Salman bin Sultan bin Abdulaziz, Governor of the Madinah Region, the third edition of the Umrah, Hajj, and Ziyarah Forum concluded its activities, marking a significant milestone in the Kingdom's mission to enhance the experience for the "Guests of Allah." This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260407456369/en/ Umrah and Ziyarah Forum Concludes in Madinah with Landmark Achievements in Pilgrim Services (Photo: AETOSWire) The final harvest of the forum resulted in exceptional numbers and a massive turnout, with more than 50,000 visitors flocking to the accompanying exhibition, which attracted over 150 exhibitors from global and local companies across an area exceeding 11,000 square meters. To enrich the knowledge aspect, the three days of the forum featured more than 160 speakers and trainers who contributed to discussions across 25 main sessions and 40 workshop
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