LivaNova Introduces Essenz In-Line Blood Monitor, Successfully Achieving U.S. FDA 510(k) Clearance and Attaining the CE Mark
Thursday, August 31, 2023
LivaNova PLC, a leading company in the medical technology sector, has made a significant announcement. The company has successfully obtained regulatory clearance from the U.S. Food and Drug Administration (FDA) through its 510(k) clearance pathway, and it has also secured the CE Mark for its innovative Essenz™ In-Line Blood Monitor (ILBM). This cutting-edge device is designed to provide accurate and continuous measurements of critical blood parameters during cardiopulmonary bypass (CPB) procedures, offering valuable support to perfusionists.
The Essenz ILBM has been seamlessly integrated into LivaNova's advanced CPB platform, known as the Essenz™ Perfusion System. This integration empowers perfusionists by allowing them to directly access and manage accurate blood parameter readings from the system's cockpit, eliminating the need for additional monitors or holders and simplifying the process.
Unlike traditional blood gas analyzers that offer snapshots of a patient's condition at a specific moment, the Essenz ILBM revolutionizes monitoring by providing continuous and real-time data on essential patient parameters throughout the entire procedure.
The Essenz ILBM stands out with its B-Capta™ sensing technology, which operates in compliance with Clinical Laboratory Improvement Amendments (CLIA) guidelines and delivers parameter values that align with those from hospital blood gas analyzers, even before alignment. This ensures accurate monitoring, with measurements for key indicators such as oxygen saturation, hematocrit, partial pressure of oxygen, and temperature, all based on direct measurements rather than calculations.
A notable advantage of the Essenz ILBM is its calibration-free nature, simplifying device setup and proving particularly valuable in emergency situations. Additionally, arterial and venous parameters are automatically transmitted to the Essenz™ Patient Monitor, supporting informed decision-making based on real-time data. This contributes to the implementation of goal-directed perfusion (GDP), an effective strategy for reducing the risk of acute kidney injury.
To enhance user experience, the latest software version 1.3 for the heart-lung machine has been developed to seamlessly integrate the ILBM with the Essenz Perfusion System. Presently, the Essenz Perfusion System is available across multiple regions, including Europe, the United States, Canada, Australia, Japan, and the United Arab Emirates. This development marks a significant step forward in elevating patient care and operational efficiency in the field of cardiovascular procedures.