LivaNova has commenced the targeted commercial launch of its Essenz Patient Monitor, following receipt of required regulatory approvals.
The device is an innovative perfusion data management system that uses a patient-tailored approach to improve clinical efficiency and the quality of patient care during cardiopulmonary bypass (CPB) procedures.
Recently, the system received 510(k) clearance from the US Food and Drug Administration (FDA) as well as CE Mark.
It was initially launched in the US and Europe for use in hospitals that were involved in the device’s user-centric design and development programme.
The Essenz Patient Monitor has been designed to help perfusionists make decisions during the complete CPB procedure and has compatibility with the LivaNova S5 heart-lung machine.
It has goal-directed perfusion (GDP) modules and an intra-operative quality indicator threshold for customised patient management strategy.
The system also features an intuitive graphical user interface (GUI) that displays patient parameters during the case.
LivaNova Cardiopulmonary president Marco Dolci said: “The Essenz Patient Monitor is the result of an intense user-centric design process we have undertaken with perfusionists.
“We worked to combine the clinical wisdom of perfusionists with our company’s legacy of providing safe and reliable cardiopulmonary equipment.
“As we look forward to the launch of the complete Essenz Perfusion System, we are eager to usher in a new era of perfusion where advanced interpretation of data provides greater value and support to perfusionists as they perform life-saving duties.”
The company stated that the Essenz Patient Monitor will also be an important feature of its Essenz Perfusion System, which is under development and anticipated to be launched in stages later this year.