LivaNova Initiates Limited Commercial Release in Europe of the Essenz Perfusion System for Cardiopulmonary Bypass Procedures

Rhea-AI Summary

LivaNova PLC (Nasdaq: LIVN) has initiated a limited commercial release of the Essenz™ Perfusion System in select European centers, following positive clinical experiences at Catharina Hospital in the Netherlands and San Donato Hospital in Italy. The innovative system integrates a next-generation heart-lung machine and a patient monitor, focusing on providing data-driven, personalized support during cardiopulmonary bypass procedures. Both components have received CE Mark, with further regulatory approvals pending in key regions. The release marks a significant advance in perfusion technology, emphasizing safety and operational flexibility.

Positive

• Initiation of a limited commercial release for the Essenz Perfusion System.
• Positive clinical experiences reported from two major hospitals.
• CE Mark received for both Essenz HLM and Patient Monitor.
• Emphasis on data-driven decision-making enhances patient care.

Negative

• None.

LONDON--(BUSINESS WIRE)-- LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology and innovation company, today announced the start of a limited commercial release for the Essenz™ Perfusion System*. The release has been initiated in select centers throughout Europe, following a successful clinical experience in two major centers, Catharina Hospital in Eindhoven, Netherlands and San Donato Hospital in Milan, Italy. Consisting of a next-generation heart-lung machine (HLM) and a transformative patient monitor, Essenz puts data at the forefront to deliver a patient-tailored approach that supports data-driven decisions during life-saving cardiopulmonary bypass (CPB) procedures.

LivaNova's Essenz™ Perfusion System (Photo: Business Wire)

Catharina Hospital was the first hospital in the world to carry out clinical cases with the Essenz Perfusion System. “We are proud to be the first to have introduced the Essenz Perfusion System to our clinical practice, particularly given the great involvement we had with the system throughout the development process,” said Eddy Overdevest, Perfusionist at Catharina Hospital. “From the first day in the operating room, we felt a level of confidence that has allowed us to immediately move into a variety of clinical cases, trusting the system and our own ability to work with it. With the Essenz Perfusion System, we’re entering a new era where technology and the expertise of the perfusionist can seamlessly come together to provide personalized care for our patients.”

“We are very satisfied with the way the machine is performing and excited to finally be able to use it to support patients during open-heart procedures,” said Mauro Cotza, Chief Perfusionist at San Donato Hospital. “We were pleased to be the first hospital in the world to place a patient on bypass with Essenz during a minimally invasive mitral valve replacement surgery.”

The Essenz Perfusion System 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. The comprehensive system provides flexibility and scalability to optimize intra-operative care coordination.

The Essenz Perfusion System is built on the legacy LivaNova S5™ HLM. The Essenz HLM cockpit and Essenz Patient Monitor are connected but operate separately. Plus, each pump on Essenz is controlled individually.

Accurate sensing technology and an intuitive dashboard on the Essenz Patient Monitor provide data during a case. With an intuitive user interface, the Essenz Patient Monitor continuously records and displays data and events together to assist the perfusionist throughout a procedure.

The Essenz Perfusion System features an ergonomic design, including advanced cable management and a mast-mounted design to keep the area clean and hygienic. The innovative cockpit provides one central view to control the device and check all perfusion and patient parameters. Mast-mounted pumps allow the user to position the disposables at their discretion (i.e., oxygenator and perfusion tubing set).

Further, 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.

“During open-heart procedures, perfusionists play a critical role and the perfusion system they use acts as the patient’s heart and lungs during the operation,” said Marco Dolci, President, Cardiopulmonary at LivaNova. “Throughout the Essenz design process, we heard directly from perfusionists that they need a flexible and reliable system that gives them access to comprehensive data to inform their patient-tailored support in the OR. With the combination of next-generation hardware and software, the Essenz Perfusion System will serve patients and empower perfusionists to make informed decisions as they provide increasingly tailored patient care.”

Both the Essenz HLM and Essenz Patient Monitor have received CE Mark and are currently pending regulatory approval in other key geographies. Learn more about the Essenz Perfusion System and Essenz Patient Monitor 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. Not available in Canada or the U.S. 510(k) clearance pending.

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 3,000 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230208005127/en/

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

Source: LivaNova PLC

FAQ

What is the Essenz Perfusion System by LivaNova?

The Essenz Perfusion System is a next-generation heart-lung machine designed to enhance data-driven decision-making during cardiopulmonary bypass procedures.

Where is the Essenz Perfusion System being released?

The limited commercial release of the Essenz Perfusion System is taking place in select centers throughout Europe.

Which hospitals participated in the initial clinical experience of the Essenz Perfusion System?

The initial clinical experience involved Catharina Hospital in the Netherlands and San Donato Hospital in Italy.

What regulatory approvals has the Essenz Perfusion System received?

The Essenz Perfusion System has received CE Mark approval and is pending regulatory approval in other key geographies.

What impact does the Essenz Perfusion System have on patient care?

The system supports personalized, data-driven decisions to improve care during open-heart procedures.