LivaNova received the US FDA 510(k) clearance for its Essenz™ Heart-Lung Machine, in March 2023. Credit: Business Wire.
The Essenz™ Heart-Lung Machine was built on the proven LivaNova S5™ HLM. Credit: Business Wire.
The Essenz™ Perfusion System uses a patient-tailored approach to improve clinical efficiency and quality of patient care during cardiopulmonary bypass procedures. Credit: Business Wire.

The Essenz™ Perfusion System was developed by UK-based medical device company LivaNova to support open-heart surgery procedures in both adult and paediatric patients.

The state-of-the-art Essenz Perfusion System integrates the next-generation Essenz Heart-Lung machine (HLM) with an intuitive Essenz Patient Monitor and precise sensing technology to facilitate informed decision-making based on data for safe cardiopulmonary bypass (CBP) management.

In February 2023, LivaNova initiated a limited commercial release of the perfusion system in select centres across Europe after experiencing its clinical benefits in two major locations, Catharina Hospital in Eindhoven, Netherlands; and San Donato Hospital in Milan, Italy.

The HLM received 510(k) clearance from the US Food and Drug Administration (FDA) in March 2023. It has also received approval from Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency.

In August 2023, the company was granted FDA 510(k) clearance and a CE Mark for the Essenz In-Line Blood Monitor (ILBM), a part of the Essenz Perfusion System. The ILBM provides accurate and continuous measurement of essential blood parameters to perfusionists throughout CPB procedures.

The Essenz ILBM enables perfusionists to directly access and manage dependable blood parameters from the system’s cockpit, eliminating the need for extra monitors or holders.

The Essenz Perfusion System is available in Europe, the US, Canada, Australia, Japan, and the United Arab Emirates (UAE).

LivaNova’s Essenz HLM design and features

Built on LivaNova’s proven S5™ HLM, the Essenz system improves both clinical workflows and patient care quality during cardiopulmonary bypass procedures.

The system consists of several components, including a blood pump, an oxygenator, a heat exchanger, and a reservoir.

The pumps of the system are mounted on a mast, which, together with sensing technology, enable perfusionists in the operating room to deliver patient-tailored perfusion therapies. The mast-mounted pumps allow for optimisation of the position of disposables such as the oxygenator and perfusion tubing set, which reduces priming volumes and haemodilution.

The mast-mounted design and advanced cable management provide an ergonomic design to the Essenz Perfusion System, minimising distractions and enabling easy cleaning.

Each pump on the system is independently controlled by a separate knob to simplify operations. The Essenz HLM cockpit provides one central view and control for minimal distractions. The cockpit and the Patient Monitor are connected but operate separately for improved reliability.

The system includes multiple features to prevent the formation of air bubbles and other potential sources of emboli from entering the patient’s bloodstream, with the help of sensor-based bubble detectors, reducing the risk of stroke and other complications.

The system is compatible with a variety of cannula sizes and configurations, making it easy to customise for each patient’s unique anatomy. The device includes a variety of safety features and alarms to help ensure appropriate levels of oxygen and blood flow to the patient and to alert the perfusionist in an emergency or if deviations from the desired perfusion parameters occur. HLM automated sensor checks confirm readiness before the beginning of the cardiopulmonary bypass procedure.

The system is capable of accommodating future software features and functionality updates.

Essenz Patient Monitor features

The Essenz Patient Monitor has an intuitive graphical user interface with a soothing background and white numbers to enhance visibility. The patient parameters are continuously recorded on the Essenz Patient Monitor during a procedure, which enhances traceability and supports the perfusionist during and after the cardiopulmonary bypass.

The monitor also features state-of-the-art software architecture, which complies with the latest medical device standards. It includes intra-operative quality indicator thresholds and goal-directed perfusion (GDP) modules to allow for individualised patient management strategy, improving its adaptability to the distinct requirements of patients, workflows, and users.

GDP is a set of parameters monitored during cardiopulmonary bypass procedures to optimise perfusion, targeting a reduction in mortality risk and postoperative complications.

The Patient Monitor can be seamlessly integrated with operating room external devices and electronic medical record systems, complying with the latest cybersecurity requirements to safeguard patient data integrity and quality.

S5 Heart-Lung Machine functioning

During open-heart surgery, the surgeon stops the patient’s heart causing it to no longer pump blood to the body’s tissues. To keep the patient alive during the procedure, the S5 heart-lung machine takes over the functions of the heart and lungs.

The S5 HLM is controlled by a perfusionist, who monitors the patient’s vital signs and adjusts the machine as needed to ensure that the patient remains stable throughout the surgery.

Essenz ILBM features

Essenz ILBM facilitates the delivery of a personalised approach to perfusion, grounded in data-driven decision-making.

Utilising the established B-Capta™ sensing technology, the Essenz ILBM stands as the sole in-line blood monitoring system compliant with Clinical Laboratory Improvement Amendments (CLIA) guidelines. It furnishes parameter values consistent with those from hospital blood gas analysers, even before alignment.

For precise monitoring, the ILBM furnishes measured values for oxygen saturation, haematocrit, partial pressure of oxygen, and temperature, rather than relying on calculated values.

Furthermore, the Essenz ILBM requires no calibration for device measurements, thereby enabling perfusionists to streamline device setup, particularly in emergency scenarios. Arterial and venous parameters seamlessly transmit to the Essenz Patient Monitor, facilitating data-driven decision-making and the implementation of GDP, a therapy recognised for mitigating the risk of acute kidney injury.

The latest HLM software, version 1.3, seamlessly integrates ILBM with the Essenz Perfusion System, signifying a commitment to ongoing user experience enhancement.