LivaNova PLC, a leading company in the field of medical technology, has announced today that it has obtained clearance from the U.S. Food and Drug Administration (FDA) through its 510(k) submission, as well as the CE Mark. These approvals pertain to the Essenz™ In-Line Blood Monitor (ILBM), an innovative device designed to ensure precise and continuous measurement of critical blood parameters for perfusionists who oversee cardiopulmonary bypass (CPB) procedures. The ILBM is seamlessly integrated into LivaNova's advanced CPB platform, known as the Essenz™ Perfusion System. This integration empowers perfusionists to directly access and manage accurate blood parameter readings from the system's control center, eliminating the need for supplementary monitors or supports.

Existing blood gas analyzers only capture a patient's clinical status at the specific moment a sample is collected, a situation that can rapidly shift and lose relevance. With the Essenz ILBM, perfusionists have continuous in-line monitoring of the patient's parameters throughout the procedure. This facilitates a personalized approach to perfusion that relies on data-informed decisions.

Marco Dolci, President of Cardiopulmonary at LivaNova, noted, "During a cardiopulmonary bypass procedure, dynamic conditions can swiftly alter a patient's blood parameters. The Essenz In-Line Blood Monitor ensures uninterrupted monitoring for the duration of the patient's procedure. Access to precise, real-time readings directly from the Essenz Perfusion System enables swift decisions and customized care strategies to benefit the patient."

Empowered by the established B-Capta™ sensing technology, the Essenz ILBM stands out as the sole in-line blood monitoring system adhering to Clinical Laboratory Improvement Amendments (CLIA) standards. It provides parameter values consistent with hospital blood gas analyzers, even prior to calibration. In contrast to calculated values, the ILBM delivers measured values for key parameters including oxygen saturation, hematocrit, partial pressure of oxygen, and temperature.

Furthermore, the Essenz ILBM doesn't necessitate calibration for configuring device measurements, which is particularly time-saving during device setup, especially in emergency scenarios. Arterial and venous parameters are automatically transmitted to the Essenz™ Patient Monitor, fostering data-driven choices and the implementation of goal-directed perfusion (GDP), a strategy effective in diminishing the risk of acute kidney injury.

The latest software version, 1.3, for the heart-lung machine integrates the ILBM with the Essenz Perfusion System, with ongoing enhancements focused on user experience.

The Essenz Perfusion System, rooted in five decades of dependable collaboration, was developed in partnership with over 300 global customers. Comprising an advanced heart-lung machine (HLM), a patient monitor, and precise sensing technology – now including the ILBM – the Essenz Perfusion System is currently accessible in Europe, the U.S., Canada, Australia, Japan, and the United Arab Emirates. Since its introduction in February 2023, over 1,000 patients worldwide have been supported by this system. Additional details about the comprehensive Essenz Perfusion System can be found on the LivaNova website.

 

Source: businesswire.com

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