The US Food and Drug Administration (FDA) has granted 510(k) clearance to LivaNova’s Essenz heart-lung machine (HLM) for use in cardiopulmonary bypass (CPB) procedures.
This clearance will enable the company to begin the US commercial launch of the Essenz machine.
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Essenz HLM has also recently been approved by Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
Following a successful limited commercial release, the company is also initiating a wider commercial launch of the system in Europe.
The company’s Essenz HLM and Essenz Patient Monitor feature the Essenz Perfusion System, which facilitates a patient-specific perfusion approach grounded in data-driven decisions.
Prior to the start of a CPB procedure, the HLM sensor checks confirm readiness.
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By GlobalDataEven though the Essenz HLM cockpit and Essenz Patient Monitor are connected, they operate independently.
Based on LivaNova S5 HLM, the Essenz Perfusion System can be adapted according to individual requirements, workflows and users.
The system uses advanced cable management and a mast-mounted design to lower distractions as well as keep the area clean and hygienic.
Its cockpit offers one central view for control of the device as well as checking all perfusion and patient parameters.
Furthermore, the system can be seamlessly incorporated with operating room (OR) external devices and hospital information systems.
Designed to support the perfusionist across a procedure, the Essenz Patient Monitor continuously records and displays data.
The technology platform can also accommodate a stream of future software features and functionalities, stated the company.
LivaNova CEO Damien McDonald said: “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.
“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.”
