LivaNova Unveils Essenz In-Line Blood Monitor with U.S. FDA 510(k) Clearance and CE Mark
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
Meilleurtaux Enters Into a Definitive Agreement to Acquire Peasy, Creating the #1 Financial Services Champion for Household Finances in Belgium23.12.2025 08:00:00 EET | Press release
Meilleurtaux, a leading omnichannel financial services brokerage platform in France, Belgium, and Luxembourg backed by Silver Lake, today announced that it has entered into a definitive agreement to acquire Peasy, a leading omnichannel broker for household finances in Flanders. Together, Meilleurtaux and Peasy will form a scaled and unified platform designed to serve Belgian households across the full spectrum of their financial needs, including mortgage credit, consumer credit and insurance. This acquisition creates a national Belgian champion that combines Peasy’s local market leadership in Flanders through key brands such as Hypotheek.winkel and Verzekeringen.be, together with Meilleurtaux’s established presence in Wallonia. It represents a further milestone in the international expansion of Meilleurtaux, which first entered the Belgian market through the acquisition of MiD Finance in 2023, and supports Meilleurtaux on its continued path to becoming a leading pan-European financial
Comera Financial Holdings, Part of Abu Dhabi’s Royal Group, and SC Ventures Announce Strategic Collaboration to Explore Innovation in SME and Beyond23.12.2025 07:05:00 EET | Press release
Comera Financial Holdings, part of Abu Dhabi’s Royal Group, and SC Ventures signed an MoU announcing a strategic collaboration to jointly explore new opportunities designed to strengthen the SME segment. The initiative reflects a shared vision to advance technology-driven financial solutions that align with the UAE’s economic priorities and support sustainable development across key sectors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251222001568/en/ Akhtar Saeed Hashmi, Managing Director & Group CEO of Comera Financial Holdings, and Alex Manson, CEO of Standard Chartered Ventures, sign an MoU announcing a strategic collaboration. (Photo: AETOSWire) Through this collaboration, Comera Financial Holdings and SCV have outlined several areas where their combined expertise can create significant value for businesses. A major focus will be on financial solutions tailored for corporates with extensive SME networks. These may in
Lattice to Showcase its Latest FPGA Technology Innovations at the International VLSID Conference23.12.2025 02:55:00 EET | Press release
Lattice Semiconductor (NASDAQ: LSCC), the low power programmable leader, today announced its exhibition plan for the upcoming International VLSID Conference taking place January 3 – 7, 2026 in Pune, India. As part of the event, Lattice Senior Vice President of Research and Development Pravin Desale will deliver a keynote presentation exploring the market dynamics and trends that are positioning low power FPGAs at the forefront of technological advancements. Lattice will also have track sessions and panel discussions on low power FPGAs and AI from edge to cloud, and technology demonstrations with industry partners focused on advanced automotive and robotics applications. Who: Lattice Semiconductor What / When (GMT+2): Lattice Demo Showcase (Major Stall #B1), Jan 5 – 7 Keynote Jan. 5, 10:30 – 11 a.m. at Main Auditorium “Powering the Future – How Low Power FPGAs are Shaping Tomorrow’s Tech Landscape” by Pravin Desale, Head of R&D, Lattice Semiconductor Track and Panel Discussions Jan. 3,
First Cessna SkyCourier Delivered into Mexico, Expanding Air Freight Capabilities for FlexCoah22.12.2025 19:13:00 EET | Press release
The first Cessna SkyCourier in Mexico was recently delivered to cargo transportation provider FlexCoah for use by the company’s aviation subsidiary, Altair. The aircraft — a freighter variant — will expand the company’s air freight capabilities throughout the country. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251222890759/en/ First Cessna SkyCourier delivered into Mexico, expanding air freight capabilities for FlexCoah (Photo Credit: Textron Aviation) The Cessna SkyCourier is designed and manufactured by Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company. “The Cessna SkyCourier’s combination of reliability, payload capacity and mission flexibility makes it a powerful asset for operators looking to scale their operations while maintaining cost-efficiency,” said Lannie O’Bannion, senior vice president, Sales & Marketing. “The delivery of the Cessna SkyCourier to FlexCoah reflects the aircraft’s growing role in tran
Proudly Produced in Donegal: ProAmpac Invests in the Future of Food Board Manufacturing22.12.2025 18:34:00 EET | Press release
ProAmpac, a global leader in flexible packaging and material science, is strengthening its operational footprint with the expansion of Food Board manufacturing capabilities at its Donegal, Ireland campus. The addition of a new, purpose-built Food Board production area within the existing site reinforces ProAmpac’s commitment to innovation, efficiency, and customer service across the food packaging sector. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251222149380/en/ Carr & Sons Smoked Salmon - ProAmpac As an extension of the existing Donegal operations, which support the pet food, food-to-go, and CPG markets, the expanded production area increases capacity and precision. A state-of-the-art guillotine system delivers cleaner cuts and consistent board quality, ensuring every sheet meets ProAmpac’s performance standards. The expanded facility area introduces several key improvements for customers: Dedicated Customer Service T
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