Analgesia Nociception Index MR Module Launched in Europe

European regulators have greenlighted the Mdoloris ANI-MR module.

Developed by MDoloris Medical Systems for Mindray, the ANI-MR module is designed for integration with the BeneVision N Series patient monitoring devices. Consequently, the ANI parameter is available to all clinicians using the Mindray’s BeneVision N Series monitoring platform. 
 
“Developed to help clinicians effectively measure the analgesia nociception level and show on the digital display, the new ANI-MR module can be seamlessly integrated into our flagship BeneVision N Series patient monitors. With clinical needs in mind, Mindray is dedicated to building a comprehensive and innovative bedside information platform through our BeneVision N Series patient monitoring system. This platform is future-proof, as it will continuously integrate more innovative technologies to empower clinicians worldwide to make professional and accurate decisions,” said Jian Cen, general manager of Mindray’s Patient Monitoring & Life Support Business Unit. 

ANI is a parameter obtained from the heart rate variability that helps clinicians to assess the autonomic nervous system, guiding the clinicians to titrate their analgesics during the surgery and anesthesia. This improves postoperative pain, PONV scores, shivering scores, and reducing post-operative opioids use,¹ as well as hospital stays,² and may reduce the Montreal scales values³—a scale used to assess post-operative cognitive disorders.

“Obtaining the CE Mark under the new Medical Device Regulation for our ANI MR module is a critical milestone for Mdoloris. The launch of the module by our partner Mindray is a major step forward, considerably strengthening MDoloris’ reach into thousands of operating rooms in Europe. This partnership will allow each clinician using the BeneVision N Series patient monitors from Mindray to get access to our ANI technology and its clinical outcomes,” said Fabien Pagniez, CEO and founder of MDoloris Medical Systems.
 
MDoloris Medical Systems is a venture-backed French company that provides clinicians continuous and non-invasive surgical stress monitoring medical devices of a patient’s parasympathetic tone. MDoloris is present in more than 70 countries, has placed more than 4,000 devices worldwide, benefitting over 300,000 patients.
 
Mindray provides medical devices and solutions in the fields of patient monitoring and life support; in-vitro diagnostics; medical imaging systems; and orthopedics. Powered by 10 R&D centers worldwide, Mindray’s products and services are in healthcare facilities in more than 190 countries and regions. Mindray’s products and solutions are now serving more than 600 teaching hospitals in Europe, the top 20 hospitals in the United States, and 99 percent of Class A tertiary hospitals in China.

References 
¹ (1) 2017- Henry D. Upton, MBBS, BMedSc (Hons), Guy L. Ludbrook, MBBS, FANZCA, PhD,Andrew Wing, BMBS (Hons), BSci (Hons), FANZCA, and Jamie W. Sleigh, MD Intraoperative“Analgesia Nociception Index”– Guided Fentanyl Administration During Sevoflurane Anesthesia in Lumbar Discectomy and Laminectomy: A Randomized Clinical Trial Anesthesia & Analgesia july 2017 doi: 10.1213/ANE.0000000000001984.
² 2020-Ramos-Luengo A, Gardeta Pallarés A, Asensio Merino F. Usefulness of ANI (analgesia nociception index) monitoring for outpatient saphenectomy surgery outcomes: an observational study. J Clin Monit Comput. 2020 Feb 28. doi: 10.1007/s10877-020-00491-1.
³ 2021- Yang, Shuyi; Xiao, Wei; Wu, Hao; Liu, Yang; Feng, Shuai;Management Based on Multimodal Brain Monitoring May Improve Functional Connectivity and Post-operative Neurocognition in Elderly Patients Undergoing Spinal Surgery Frontiers in Aging Neuroscience , Volume 13 – Jul 15, 2021 10.3389/fnagi.2021.705287