LivaNova receives FDA 510(k) approval for new in-line blood monitor

Editor's Note

The Essenz™ In-Line Blood Monitor (ILBM) has received U.S. FDA 510(k) clearance and CE mark, as announced by manufacturer LivaNova on August 30.

The new ILBM provides “accurate and continuous measurement of essential blood parameters for perfusionists throughout cardiopulmonary bypass procedures,” and integrates with the company’s Essenz Perfusion System, allowing access to manage reliable feedback without additional monitors.

Essenz™ is the only ILBM system that operates within Clinical Laboratory Improvement Amendments (CLIA) guidelines, providing measured values for oxygen saturation, hematocrit, partial pressure of oxygen and temperature.

LivaNova president of cardiopulmonary, Marco Dolci, noted, “Dynamic conditions can rapidly change a patient’s blood parameters during a cardiopulmonary bypass 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.”

LivaNova is a global medical technology company offering improvements for both the head and heart in more than 100 countries worldwide.