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
The Estée Lauder Companies Unveils Mastering Skin Longevity, a Breakthrough Scientific Innovation Platform Advancing the Next Era of Skin Science6.11.2026 16:00:00 EET | Press release
At the China International Import Expo (CIIE), The Estée Lauder Companies Inc. (NYSE: EL) today unveiled Mastering Skin Longevity, a breakthrough scientific innovation platform designed to advance the next era of skin science and transformative product innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261106776704/en/ The Estée Lauder Companies' Skin Longevity Clock serves as the visual representation for the Mastering Skin Longevity scientific innovation platform. Moving beyond the study of individual Hallmarks of Aging, the platform focuses further upstream on the Master Regulators of Skin Longevity. These interconnected biological pathways and proteins influence multiple hallmarks at once. By deepening understanding of these systems and how they help support skin’s ability to repair, adapt and regenerate, Mastering Skin Longevity will guide the Company’s discovery across ingredients, technologies, formulations an
IntouchCX Recognized for Operations led AI and End to End CX Transformation by HFS Research6.11.2026 16:00:00 EET | Press release
IntouchCX a global leader in AI-powered customer experience (CX) management, trust and safety, digital engagement, and back-office operations, has been positioned in the Horizon 2 end-to-end experience transformation, in the HFS Horizons Customer Experience Services 2026 report for its operations led approach to AI adoption and its model connecting advisory with delivery, from strategy through frontline executions. HFS Research evaluates customer experience service providers based on their capabilities, innovation, and potential to deliver value. The 2026 report examines how providers are helping businesses adopt AI, improve customer experiences and strengthen operations. “AI transformation delivers the greatest value when strategy, technology, and operations work together,” said Brent Stevenson, Chief Experience Officer at IntouchCX. “Our approach and expertise goes beyond technology. We identify business challenges and build the right solutions by connecting the dots between data, wo
Experian Named a Leader in 2026 IDC MarketScape for Worldwide Decision Intelligence Platforms6.11.2026 16:00:00 EET | Press release
Experian today announced it has been named a Leader in the IDC MarketScape: Worldwide Decision Intelligence Platforms 2026 Vendor Assessment (Doc #US54118426, September 2026), which evaluates providers helping organizations design, engineer and orchestrate increasingly complex decisions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261106302874/en/ IDC MarketScape positions Experian as a Leader in its 2026 vendor assessment of worldwide decision intelligence platform providers. “As organizations embed AI into more consequential decisions, the combination of trusted data, advanced analytics and strong governance becomes increasingly important,” said Keith Little, President of Experian Software Solutions. “Experian brings those capabilities together with decisioning, fraud and identity to help organizations make better decisions with greater speed and confidence.” The Experian Ascend Platform provides a unified analytics and
Midas Atlantic Partners, in Partnership With the Najafi Companies, Has Entered Into a Put Option Agreement With Sylvamo Relating to the Potential Acquisition of Its European Operations6.11.2026 13:04:00 EET | Press release
Midas Atlantic Partners (“Midas Atlantic”), in partnership with The Najafi Companies, has signed a put option agreement with Sylvamo Corporation (“Sylvamo”) relating to the potential acquisition of its European operations (the “Business”). The transaction comprises Sylvamo’s uncoated freesheet paper mills in Saillat and Nymölla, as well as its forestry and supporting business operations across Europe. Closing is expected in the first quarter of 2027, once the required consultation processes are completed and regulatory approvals are obtained. The Business is a leading European producer of uncoated woodfree (UWF) paper for office and commercial printing. Its product portfolio spans cut-size office paper, sold under its own brands such as REY and Multicopy as well as on behalf of major OEM and office supplies customers, and paper reels for commercial printers and converters. Headquartered in Belgium, with two large-scale, vertically integrated pulp and paper mills, it serves a longstandi
Suzano Reports 36% Increase in Third Quarter Net Revenue Following Consolidation of Arbex6.11.2026 01:23:00 EET | Press release
Suzano (B3: SUZB3 / NYSE: SUZ) , the world’s largest pulp producer, announces its results for the third quarter of 2026 (3Q26), which for the first time include Arbex, the joint venture between Suzano and Kimberly-Clark established in July this year. Driven primarily by the consolidation of Arbex’s contribution, Suzano reported net revenue of BRL16.5 billion, an increase of 36% on the same period last year and a new quarterly record in the company’s 102-year history. Adjusted EBITDA totaled R$5.7 billion in 3Q26, up 9% on the same basis of comparison. Operating cash generation reached R$3.8 billion, an increase of 12%. Net income totaled R$2.1 billion. As announced following the completion of the transaction with Kimberly-Clark, Suzano holds a 51% equity interest in Arbex and will therefore fully consolidate the joint venture’s financial statements from this quarter onwards.1 “This quarter marks the beginning of a new phase for Suzano. With Arbex, we are now a broader business, both ge
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