UK-based medical technology firm LivaNova announced the receipt of necessary approval and the start of a targeted commercial launch for its Essenz Patient Monitor device.
The device, compatible with the LivaNova S5 heart-lung machine, employs a patient-specific strategy to improve clinical efficiency and patient care during cardiopulmonary bypass (CPB) surgeries.
The monitoring system (Essenz), recipient of US Food and Drug Administration (FDA) 510(k) clearance and CE Mark, was initially launched in the US and Europe hospitals that were involved in its user-centric design and development program.
Furthermore, the patient monitor is compatible with the LivaNova S5TM heart-lung machine which will assist the perfusionist to make critical decisions throughout the CPB process and is based on 30-year experience of LivaNovaand extensive collaboration with perfusionists.
According to the company, the device has an intra-operative quality indicator threshold and goal-directed perfusion modules for customised patient management strategy.
Essenz Patient Monitor has an intuitive graphical user interface (GUI) that displays patient parameters during the case which helps to keep a watch on the patient’s condition.
Its advanced software architecture can easily integrate with operating room external devices and electronic medical record systems, thus safeguarding patient data integrity and quality.
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 device will be a key feature of the company’s Essenz Perfusion System, which is currently under development and is expected to launch in stages later this year.
