LivaNova Receives U.S. FDA 510(k) Clearance for Essenz Heart-Lung Machine for Cardiopulmonary Bypass Procedures
10.3.2023 00:05:00 EET | Business Wire | Press release
LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology and innovation company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Essenz™ Heart-Lung Machine (HLM). With FDA clearance, LivaNova initiates the commercial launch of Essenz in the U.S. The Company also recently received approval for the Essenz HLM from Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Additionally, LivaNova is initiating a broad commercial release in Europe, following a successful limited commercial release that supported more than 200 adult, pediatric and neonatal patients in Europe. The Essenz HLM and Essenz™ Patient Monitor comprise the Essenz™ Perfusion System, which enables a patient-tailored perfusion approach rooted in data-driven decisions that improve both clinical workflows and quality of patient care during cardiopulmonary bypass (CPB) procedures.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230309005787/en/
LivaNova's Essenz™ Perfusion System (Photo: Business Wire)
“The Essenz Perfusion System has tremendous potential to become a key addition to our clinical practice, fusing a new era of technology with the skill and expertise of the perfusionist,” said Larry Garrison, Chief Perfusionist at Franciscan Health Indianapolis in Indianapolis, Indiana. “Since we participated in the Essenz HLM validations and the early release of the Essenz Patient Monitor, we’ve witnessed the System’s immense ability to unlock the potential of individualized care throughout all phases of CPB procedures.”
Essenz is based on 50 years of trusted partnership with perfusionists. LivaNova worked hand in hand with more than 300 perfusionists around the world who participated during every step of design and development to address their evolving needs in the operating room (OR), with an emphasis on patient safety and risk management.
Key attributes of the Essenz Perfusion System include:
Safe and Reliable:
The system is built on the proven LivaNova S5™ HLM, which has supported millions of patients for safe CPB procedures. Each pump on Essenz is controlled individually for simple, straightforward operations. HLM sensor checks confirm readiness before the CPB procedure starts. The Essenz HLM cockpit and Essenz Patient Monitor are connected but operate separately to further ensure reliability.
Patient-Tailored Care:
Accurate sensing technology and an intuitive dashboard on the Essenz Patient Monitor provide critical data to support individualized, data-driven patient care during a case. Essenz Patient Monitor utilizes official formulas to support perfusionists in the implementation of goal-directed perfusion (GDP), a therapy effective in reducing the risk of acute kidney injury.1 Mast-mounted pumps allow the user to optimize the position of the disposables (i.e., oxygenator and perfusion tubing set), which minimizes priming volumes and reduces hemodilution.
Intuitive:
The Essenz Patient Monitor offers an intuitive user interface and continuously records and displays data and events together to assist the perfusionist throughout a procedure. Data is automatically and seamlessly transferred, minimizing manual data entry and freeing up valuable time for the perfusionist in the OR. The technology platform is built to accommodate a stream of future software features and functionalities, making it a valuable long-term investment.
Flexible and Efficient:
The Essenz Perfusion System can be adapted to the individual needs of patients (adult and pediatric), workflows and users. It features an ergonomic design, including advanced cable management and a mast-mounted design that minimizes distractions and keeps the area clean and hygienic. The innovative cockpit provides one central view to control the device and check all perfusion and patient parameters. Also, Essenz has seamless integration with OR external devices and hospital information systems.
In addition, the Essenz Perfusion System is backed by a responsive service team of dedicated, local engineers in more than 100 countries, along with a global support center to address any needs.
“A perfusion system acts as a patient’s heart and lungs during an open-heart procedure, so having the highest-quality system backed by the expertise of a skilled perfusionist is paramount,” said Damien McDonald, Chief Executive Officer of LivaNova. “When we were designing Essenz, perfusionists told us they needed a system that gives them access to comprehensive data to drive more informed decision-making throughout the entire procedure. We’ve done that with Essenz. Through next-generation hardware and software, Essenz empowers perfusionists to better serve their patients with increasingly tailored care.”
Learn more about the entire Essenz Perfusion System on the LivaNova website.
*Note: The Essenz Heart-Lung Machine is not available for sale in all geographies. Visit the LivaNova website for important safety information.
References
-
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 and innovation company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through innovative 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 and the Essenz Patient Monitor. 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/20230309005787/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
Introducing Arbex: a New Global Leader in Tissue and Hygiene1.7.2026 14:37:00 EEST | Press release
Arbex, a new global leader in tissue and hygiene, today commences operations as an independent business and unveils details of its brand, leadership team, and company structure. Announced in June 2025 as a $3.4 billion joint venture between Suzano (NYSE: SUZ), the world’s largest pulp supplier, and Kimberly-Clark Corporation (NASDAQ: KMB), a global leader in consumer goods and personal care, the new business will manufacture, market and distribute consumer and professional products across more than 70 markets on five continents. Arbex has assumed ownership of assets previously run by Kimberly-Clark’s International Family Care & Professional (IFP) business unit, which includes 22 manufacturing sites in 14 countries, and a portfolio of more than 40 regional brands including Andrex®, Hakle®, and Scottex®. The company also holds a long-term license for the use of Kimberly-Clark’s global brands, including Kleenex®, Cottonelle®, Scott®, WypAll®, Viva®, and Kimberly-Clark Professional. Ehab A
Klarna has received a favorable ruling in PriceRunner litigation, awarding damages of $1.97 billion1.7.2026 14:19:00 EEST | Press release
Klarna Group plc (NYSE: KLAR) today announces that the court has ruled in PriceRunner’s favor, awarding $1.97 billion in damages in an antitrust case brought by PriceRunner against Google. The award compensates for lost revenue caused by Google's preferential treatment of its own comparison-shopping service over independent price-comparison services, conduct that also drives up costs for consumers. "When markets work well, everyone benefits. Consumers get higher quality at lower cost, companies stay focused on serving customers rather than defending position, and society is better off for it. This ruling supports a healthier, more competitive market for the way people compare products and services — and that is good for everyone who shops," said Dan Greaves, Head of Communications and Policy, Klarna. Klarna acquired PriceRunner in 2022 to add rich product discovery, price comparisons, and product reviews to the Klarna app, and drive high-intent traffic to retail partners. Klarna has si
Objectway Acquires Swiss Private Banking Technology Business From FNZ to Strengthen Its Pan-European Positioning1.7.2026 14:10:00 EEST | Press release
Objectway, a global wealthtech partner for banking, wealth and asset management firms, today announced the acquisition from FNZ of their Swiss private banking technology business FNZ Switzerland SA (formerly operating as New Access). The business will now be operated under the Objectway Switzerland brand. Objectway welcomes a team of over 160 professionals, bringing their expertise and professionalism honed in developing innovative, award-winning solutions for over 40 private banks. The acquisition is a significant step in Objectway’s growth strategy, reinforcing its commitment to expanding its presence in key international wealth hubs such as Switzerland, Liechtenstein, Luxembourg, Monaco and the Bahamas, where the newly joined business already serves both domestic and international cross-border clients. The agreement further expands Objectway’s scalable core-to-digital capabilities supporting end-to-end private banking operations, while leveraging an international team and operationa
NIQ Completes Acquisition of Flywheel’s China and Southeast Asia eCommerce Data & Insights Business, Expanding Digital Commerce Intelligence Capabilities1.7.2026 14:00:00 EEST | Press release
NielsenIQ (NYSE: NIQ), a leading consumer intelligence company, today announced that it has completed the acquisition of Flywheel’s China and Southeast Asia eCommerce Data & Insights business. The acquired business operates in China under the YiMian (“一面”) brand and is a leading provider of eCommerce, social commerce, and digital shelf solutions. The acquisition expands NIQ’s capabilities across China and Southeast Asia and strengthens its ability to measure and understand consumer behavior across retail, eCommerce, social commerce, and digital environments — advancing NIQ’s mission to deliver The Full View™, the most complete understanding of consumer behavior across online and offline channels. It also enhances NIQ’s data and analytics foundation by expanding access to rich digital commerce signals that support the development of more advanced analytics and AI-powered solutions. By bringing together NIQ’s global intelligence, analytics, and retail measurement capabilities with the ac
Azalea Vision Awarded Prestigious EIC Accelerator Funding to Advance Smart Contact Lens into Clinical Development1.7.2026 14:00:00 EEST | Press release
Azalea Vision, a Belgian healthtech company building the first medical-grade smart contact lens, today announced it has been selected for the European Innovation Council (EIC) Accelerator, the European Union’s flagship program for breakthrough, market-creating deep tech. Azalea is the only Belgian company selected in this round and will receive up to €7.5 million, including a non-dilutive €2.5 million grant and a planned €5 million equity investment from the EIC Fund, to advance its medical-grade smart contact lens platform into clinical development. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260701144267/en/ Azalea Vision Co-founder and CTO Andrés Vásquez Quintero undergoing an on-eye evaluation of the ALMA smart contact lens. Beyond the funding, the award is a strong external endorsement of Azalea’s technology and long-term vision. Built on its proprietary smart contact lens platform, Azalea’s smart lens is designed to
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