Masimo Has Secured the CE Mark under the EU Medical Device Regulation (Mdr) For Its Lidco® Module, Developed for the Purpose of Hemodynamic Monitoring

Monday, October 09, 2023

Masimo has recently announced that it has obtained the CE mark certification under the European Union Medical Device Regulation for its LiDCO® board-in-cable (BIC) module. This module is specifically designed to seamlessly integrate with multi-patient monitoring platforms, including the Masimo Root® Patient Monitoring and Connectivity Hub, enhancing hemodynamic monitoring capabilities.

With the LiDCO BIC module, healthcare professionals can easily incorporate advanced LiDCO hemodynamic monitoring into their Root patient monitoring hubs. This module is designed to be compatible with various pressure transducers, providing flexibility to clinicians and healthcare facilities. It's a significant development because it allows hemodynamic monitoring alongside other supported parameters without requiring a dedicated hemodynamic monitoring device.

The LiDCO module offers comprehensive support, including powerful guided protocols for assessing fluid responsiveness, trend data, and real-time notifications for beat-by-beat pressure analysis. These data can be displayed in optimal configurations for individual patients on the Root monitor. The combination of Masimo's rainbow® Pulse CO-Oximetry and LiDCO hemodynamic monitoring promises valuable new insights into patient status.

Joe Kiani, the Founder and CEO of Masimo, underscored the significance of this accomplishment, explaining, "Introducing LiDCO's advanced beat-to-beat hemodynamic monitoring to the Masimo Root platform opens up the potential for delivering a more comprehensive, continuous assessment of cardiac output (CO) and oxygen delivery (DO2). Presently, hemodynamic monitors can offer ongoing analysis of blood pressure data but depend on sporadic information from other monitors for oxygenation, providing clinicians with only partial insights. By harnessing both Masimo's groundbreaking noninvasive rainbow SET® Pulse CO-Oximetry parameters and LiDCO's innovative PulseCO algorithm, clinicians can now access a continuous, concurrent display of all the elements that constitute a patient's oxygen delivery, DO2 – including cardiac output (CO), stroke volume (SV), pulse rate (PR), total hemoglobin (Masimo SpHb®), and fractional oxygen saturation (Masimo SET® SpO2 adjusted for dyshemoglobins, SpCO® and SpMet®) – alongside an automated DO2 estimation. These data can be presented side by side, in real-time and continuously, on the high-resolution screen of the Root monitor. We are thrilled about the implications of this for surgical and critical care patients, as their clinicians can finally access real-time continuous data from the remarkable synergy of LiDCO and rainbow®, providing a continuous oxygen delivery indicator."

The LiDCO module is designed for straightforward setup and versatile operation, using a patient's existing arterial line and blood pressure transducer to monitor a wide range of advanced hemodynamic parameters through the powerful beat-by-beat PulseCO algorithm. This beat-by-beat analysis provides prompt feedback on fluid and hemodynamic status, avoiding delays common with other hemodynamic monitors that rely on assumptions about vascular compliance or the detection of the dicrotic notch. Its streamlined board-in-cable design ensures seamless compatibility with the Root monitor and other multiparameter platforms, eliminating the need to add a dedicated hemodynamic monitor to already crowded operating rooms and intensive care units.

Healthcare professionals, such as Dr. Max Jonas from Southampton General Hospital in the U.K., have expressed enthusiasm for this development, highlighting the clinical significance of dynamic hemodynamic monitoring and its positive impact on patient outcomes. Additionally, Dr. Daniela Chaló, MD, PhD, Head of Anesthesiology at Centro Hospitalar Baixo Vouga in Portugal, praised the LiDCO monitor for its advantages in hemodynamic monitoring, ease of integration, and its ability to consolidate critical patient information onto a single monitor.

Clinical studies have demonstrated that the use of LiDCO can lead to reduced postoperative complications, lower costs, and even decreased mortality rates at 30 and 180 days after surgery. In one study involving 743 patients undergoing major abdominal surgery, hemodynamic optimization with LiDCO resulted in a 20% reduction in postoperative complications and cost savings. Another study involving 600 emergency laparotomy patients showed a significant decrease in mortality at both 30 and 180 days following the implementation of a program featuring LiDCO technology.

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