Masimo SEDLine brain function monitor receives CE Mark

Masimo (NASDAQ: MASI) announced today that it has received CE Mark for its SEDLine brain function monitor — expanding  access to and availability of SEDLine's advanced neuromonitoring technology to hospitals and clinicians across Europe.  The only brain function monitor with four separate EEG channels in a single integrated algorithm SEDLine represents a critical advancement for the practice of anesthesia in Europe — more complete data for a more complete picture of brain function and sedation.    

SEDLine expands the scope of real-time data and improves the management of an anesthetic case by enabling more individualized titration.  Four channels of high-quality EEG data provide information about both sides of the brain to facilitate immediate detection of asymmetrical activity and yields a single sophisticated algorithm to give accurate, reliable information about a patient's response to anesthesia.  Masimo's SEDLine Patient State Index (PSI™), a calculated measure of brain activity that reflects the patient's current level of sedation/anesthesia, provides additional data to enhance anesthetic control and facilitate rapid assessment.  With demonstrated reliability under challenging clinical conditions and superior resistance to cautery, SEDLine offers a cost-effective solution for brain function monitoring that helps clinicians achieve targeted sedation throughout all phases of anesthesia — in the OR and ICU.

According to Michael Ramsay, M.D., Chief of Anesthesiology and Pain Management & President of the Research Institute at Baylor University Medical Center in Dallas, Texas, "For many of the liver transplants and cardiac anesthesia cases I participate in, SEDLine provides me with real-time access to more comprehensive brain activity data, which is especially critical when a surgical patient's hemodynamic parameters are rapidly changing.  Because of SEDLine's unique four separate EEG channels in a single integrated algorithm — enabling greater control and sedation management — I believe it will also complement the use of Target Control Infusion narcotic based anesthesia, which is a widely used technique in Europe."

The introduction of EEG-based monitoring systems such as SEDLine to provide guided titration has been shown to reduce the amount of anesthetic used and decrease recovery time when used as an adjunct to current standard clinical practice. In fact, these studies show that SEDLine PSI facilitated more individualized titration of anesthesia that led to patients receiving significantly less anesthetic and recovering an average of 67% faster — ultimately enabling faster OR to PACU throughput with patients meeting discharge eligibility 19% faster than non-SEDLine-monitored patients.  

Masimo Founder and CEO, Joe Kiani, stated:  "The risks associated with the expanded use of short-acting anesthetic drugs like Propofol, where patients go in and out of the sedation state very quickly, makes it increasingly important for anesthesiologists to maintain tighter control.  Masimo's SEDLine PSI and our popular 4-channel waveforms help anesthesiologists keep their patients where they want them to be — improving sedation control and the management of anesthetized patients."