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
Sitetracker and 5x5 Break the Price Barrier for Portfolio-Scale Digital Twins and Asset Intelligence23.9.2026 13:11:00 EEST | Press release
Sitetracker and 5x5 Technologies today introduced a data-to-twin workflow that gives wireless infrastructure owners a practical, affordable path to digitizing an entire tower portfolio. The Sitetracker platform now integrates 5x5 Synthetic Twin technology, providing scalable asset intelligence at a price up to 85% less than traditional site modeling methods. Synthetic Twins leverage Sitetracker’s leading tower portfolio and operational data to create interactive 3D models of towers, rooftops and ground compounds providing tower operators with a baseline of their portfolio that can be progressively enriched as the site conditions evolve. This data when combined with Scout, Sitetracker’s Agentic AI platform, opens the opportunity for digitized workflows and unparalleled understanding of the asset portfolio. Why it matters AI-driven data demand, more spectrum deployments, and denser infrastructure are raising the bar for tower operations. Towercos need precise knowledge of each site: what
LTM Launches BlueVerse™ SovereignSphere™ Models to Help Enterprises Own Their AI Advantage23.9.2026 13:05:00 EEST | Press release
LTM, the Business Creativity partner to the world's largest enterprises, today launched BlueVerse™ SovereignSphere™ Models, enabling organizations to transform proprietary knowledge into AI capabilities that understand their business context and operate within their governance boundaries. BlueVerse SovereignSphere Models enable enterprises to overcome critical AI adoption challenges by lowering infrastructure costs, simplifying governance, and reducing reliance on generic AI models. It helps organizations build AI that understands their business, language, workflows, policies, and domain expertise as a native capability. Enterprises retain ownership of their models and intellectual property while benefiting from more predictable AI economics and reduced dependence on token-heavy architectures. The key offerings in the portfolio include: Sales and Marketing Pro – Delivers CRM architect-level expertise across solution design, code generation, troubleshooting, and root-cause analysis, hel
Cox Capital Announces Tender Offers for Class I Shares of Blackstone Private Credit Fund and HPS Corporate Lending Fund23.9.2026 13:00:00 EEST | Press release
Cox Capital Partners (“Cox Capital”) announced today that Cox Capital Retail Secondaries Fund I, LP (the “Purchaser”), a private investment fund managed by an affiliate of Cox Capital, has commenced two separate cash tender offers to purchase Class I shares of Blackstone Private Credit Fund (“BCRED”) and HPS Corporate Lending Fund (“HLEND”). Both funds recently reported that their Q3 2026 repurchase programs were substantially oversubscribed. BCRED and HLEND received repurchase requests representing an estimated 10% and 11.5%, respectively, of shares outstanding. The funds’ established frameworks generally target quarterly repurchases of 5% of shares outstanding, although the amount may be increased at the discretion of the applicable fund. Cox Capital developed its secondary program to provide shareholders with an additional path to liquidity when a fund's own quarterly repurchase program does not satisfy their full request. The offers are independent of the target funds and do not mo
Three Weeks into France E-Invoicing Mandate: Sovos Hits Unparalleled Production Scale23.9.2026 11:00:00 EEST | Press release
Sovos, the agentic tax compliance company, today announced that it has surpassed 170,000 organizations registrants across the Sovos-powered network – including both Sovos-branded and partner-branded approved service providers - using Sovos technology in France. By comparison, the nearest competitors registered fewer than 2,200 organizations each. The milestone represents a significant lead in production-grade e-invoicing, with Sovos handling transaction volumes that are many multiples higher than any other tax compliance vendor operating in France. "France represents the most complex continuous transaction controls mandate the world has seen, and we entered production on day one with our Global 2000 clients fully live," said Kevin Akeroyd, CEO, Sovos. "We achieved the highest industry percentage of effective go-lives not only for these clients, but for the hundreds of technology providers who embed our e-invoicing to service hundreds of thousands of end user businesses in France. This
Mentimeter Launches Three New Tools for Better Leadership23.9.2026 10:00:00 EEST | Press release
Mentimeter is launching an engagement suite with three new tools: Menti Live, Menti Form and Menti Pulse. Through interaction, insights and recommendations, the new suite enables organizations to engage people live, collect input asynchronously and track important signals over time. Today’s launch expands Mentimeter’s platform beyond live presentations, helping turn participation into new ways of understanding what people think, know and need. “Most organizations have plenty of data, but surprisingly little understanding of what their people actually think. These new tools give leaders a way to turn participation into company-wide performance – in the room, afterward and over time. That creates better input for action and, ultimately, better leadership,” says Johnny Warström, CEO and founder of Mentimeter. Three tools for different moments of engagement Menti Form collects input asynchronously. It allows for shared reflection and gives people the opportunity to contribute regardless of
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