LivaNova Unveils Essenz In-Line Blood Monitor with U.S. FDA 510(k) Clearance and CE Mark - Seite 2

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

1. Ottens J. et all. Improving Cardiopulmonary Bypass: Does Continuous Blood Gas Monitoring Have a Role to Play? - JECT. 2010;42:191–198
2. 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
3. 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
4. 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.

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The LivaNova Stock at the time of publication of the news with a raise of 0,00 % to 51,25EUR on Lang & Schwarz stock exchange (30. August 2023, 22:09 Uhr).