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
Klarna Card reaches 5 million active customers19.3.2026 16:31:00 EET | Press release
Klarna, the global digital bank and payments provider, today announced that the Klarna Card has reached 5 million active customers globally, underscoring rapid adoption as consumers shift towards new forms of payment which provide more control over day-to-day money management. The card draws from the customer's own funds for everyday spending, with the option to spread the cost of a specific purchase, like a large appliance or a flight, when it makes sense to do so. The result is a card that offers genuine spending control without the long-term debt obligations that come with traditional credit cards. The card’s growth is reinforced by Klarna’s membership program. The program offers premium perks such as airport lounge access, travel insurance, and lifestyle subscriptions — without requiring users to take on debt, meet spending thresholds, or revolve balances. By separating everyday spending from rewards, Klarna is challenging the strings-attached model legacy banks have long relied on
Andersen Consulting Expands Technology Platform in France19.3.2026 15:30:00 EET | Press release
Andersen Consulting expands its digital transformation offering through a Collaboration Agreement with Teolia Consulting, a French firm specializing in project and product management, cloud platform engineering, data transformation, and Atlassian suite integration and adoption. Founded in 2014, Teolia Consulting helps organizations achieve digital performance, from agile methodology to time-to-market solutions. The firm’s expertise is focused on delivering integrated strategies that align technology with organizational change. The firm works across industries including banking, insurance, fashion, and retail, empowering clients to strengthen resilience and accelerate digital maturity. “At Teolia Consulting, we believe that true transformation happens when technology and people evolve together,” said Lucienne Jacquet, managing partner of Teolia. “By collaborating with Andersen Consulting, we not only amplify our impact but also gain access to a worldwide organization of like-minded indi
Stonebranch Releases 2026 Global State of IT Automation Report, Revealing Orchestration as the Missing Link for AI Adoption and Trust19.3.2026 15:30:00 EET | Press release
Stonebranch, a leading provider of service orchestration and automation solutions, today released its annual 2026 Global State of IT Automation Report, the company’s most comprehensive research study to date. Based on responses from 402 IT automation professionals spanning C-suite executives to individual contributors across North America, EMEA, Latin America, and APAC, the report provides a detailed, data-driven portrait of how enterprises are investing in, deploying, and deriving value from IT automation in 2026. “This year’s findings highlight an important shift in how organizations approach automation,” said Giuseppe Damiani, CEO of Stonebranch. “Organizations are now building automation as strategic infrastructure — a governed, scalable foundation that spans hybrid environments, operationalizes AI, and delivers automation-as-a-service to thousands of users across the enterprise. The companies that get orchestration right are not just running more efficient IT operations. They are
Perma-Pipe Accelerates Growth with New U.S. Northeast Facility Investment to serve Artificial Intelligence Data Center customers, Provides Middle East Operations’ Update and Concludes the Board’s Review of Strategic Alternatives19.3.2026 15:00:00 EET | Press release
Perma-Pipe International Holdings, Inc. (the “Company”) today announced a strategic expansion initiative focused on accelerating growth through entry into the high-demand U.S. Northeast region. The Company is positioning itself to capitalize on the rapidly expanding Artificial Intelligence (“AI”)-driven data center market in both the United States and international markets while continuing to reinforce its leadership in critical infrastructure solutions. As part of this growth strategy, Perma-Pipe will prioritize investments aimed at expanding its presence in the rapidly evolving AI data center sector. The initiative reflects the Company’s long-term commitment to supporting next-generation technology infrastructure and strengthening its position in the global energy, industrial, and infrastructure markets. Expansion in the U.S. Northeast President & Chief Executive Officer, Saleh Sagr said, “We are excited to announce the expansion of our operations with a new facility in the Northeast
Armis Launches First-of-Its-Kind Benchmark Report Warning of Critical Security Gaps in AI-Native Development19.3.2026 14:00:00 EET | Press release
Armis, the cyber exposure management & security company, is warning that the rapid enterprise adoption of AI-native development is outpacing critical security safeguards, leaving organizations exposed to systemic vulnerabilities. New research from Armis Labs’ Trusted Vibing Benchmark Report, which evaluates 18 leading generative AI models across 31 test scenarios, reveals a 100% failure rate in generating secure code. These vulnerabilities are most prevalent in high-risk areas like memory buffer overflows, design file uploads and authentication systems. Therefore, organizations should immediately implement AI-native application security controls to reduce risk. “The era of vibe coding is here, but speed should not come at the cost of security,” said Nadir Izrael, CTO and Co-Founder of Armis. “Our research finds that the worst offenders are the same ones selling security solutions for the very vulnerabilities their models create. If the industry continues to integrate autonomous code wi
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