LivaNova wins FDA clearance for Essenz in

August 30, 2023 By Sean Whooley

Essenz ILBM provides accurate and continuous measurement of essential blood parameters throughout cardiopulmonary bypass (CPB) procedures. It integrates into the next-generation Essenz perfusion system. Essenz enables perfusionists to access and manage reliable blood parameters directly from the system’s cockpit. It eliminates the need for additional monitors or holders.

London-based LivaNova says that existing blood-gas analyzers only reflect the patient’s clinical condition at the exact moment a sample is drawn. This sample can quickly change and the analysis becomes irrelevant. Essenz ILBM provides in-line, continuous monitoring for the duration of a procedure. LivaNova said this allows for the delivery of a patient-tailored approach to perfusion rooted in data-driven decisions.

B-Capta sensing technology powers Essenz ILBM, enabling it to provide parameter values in line with hospital blood-gas analyzers. It provides measured values for oxygen saturation, hematocrit, partial pressure of oxygen and temperature. The alternative, LivaNova said, is calculated values for these parameters.

Essenz ILBM also requires no calibration to set device measurements, saving perfusionists time. Arterial and venous parameters automatically transfer to the Essenz patient monitor, supporting decision-making and goal-directed perfusion.

“Dynamic conditions can rapidly change a patient’s blood parameters during a cardiopulmonary bypass procedure,” said Marco Dolci, LivaNova president, cardiopulmonary. “The Essenz In-Line Blood Monitor provides continuous monitoring throughout a patient’s procedure. Access to accurate, real-time measurements directly from the Essenz perfusion system allows for quick decisions and tailored care strategies to serve the patient.”

Filed Under: 510(k), Blood Management, Cardiovascular, Food & Drug Administration (FDA), Health Technology, Regulatory/Compliance, Vascular Tagged With: LivaNova